Trial Outcomes & Findings for A Study of the Antiplatelet Effects Comparing Ticagrelor (Ticag. - AZD6140) With Clopidogrel (Clop.) Responder and Non-responders (NCT NCT00642811)

Last Updated: 2011-10-04

Results Overview

The primary definition of response to treatment is IPA \>10% post treatment. The response is reported as percentage of participants of each treatment. Please refer to the protocol section for details about the interventions administered. IPA(%)=(PAb-PAt)/PAb\*100. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

98 participants

Primary outcome timeframe

Day 14 and Day 28, 4 Hrs Post Dose.

Results posted on

2011-10-04

Participant Flow

Participant milestones

Participant milestones
Measure	Clopidogrel Non-responders - Clopidogrel to Ticagrelor Non-responder definition: patients with an absolute difference of less than or equal to 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist. Clopidogrel 600 mg loading dose followed by 75 mg once daily (od) for 2 weeks; switch to ticagrelor 180 mg loading dose followed by 90 mg twice daily (bd) for 2 weeks.	Clopidogrel Non-responders - Ticagrelor to Clopidogrel Non-responder definition: patients with an absolute difference of less than or equal to 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist. Ticagrelor 180 mg loading dose followed by 90 mg twice daily (bd) for 2 weeks; switch to clopidogrel 600 mg loading dose followed by 75 mg once daily (od) for 2 weeks.	Clopidogrel Responders - Clopidogrel to Clopidogrel Responder definition: patients with an absolute difference greater than 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist. Clopidogrel 600 mg loading dose followed by 75 mg once daily (od) for 2 weeks; stay on clopidogrel 75 mg once daily (od) for 2 weeks	Clopidogrel Responders - Clopidogrel to Ticagrelor Responder definition: patients with an absolute difference greater than 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist. Clopidogrel 600 mg loading dose followed by 75 mg once daily (od) for 2 weeks; switch to ticagrelor 180 mg loading dose followed by 90 mg twice daily (bd) for 2 weeks.	Clopidogrel Responders - Ticagrelor to Clopidogrel Responder definition: patients with an absolute difference greater than 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist. Ticagrelor 180 mg loading dose followed by 90 mg twice daily (bd) for 2 weeks; switch to clopidogrel 600 mg loading dose followed by 75 mg once daily (od) for 2 weeks.	Clopidogrel Responders - Ticagrelor to Ticagrelor Responder definition: patients with an absolute difference greater than 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist. Ticagrelor 180 mg loading dose followed by 90 mg twice daily (bd) for 2 weeks; stay on ticagrelor 90 mg twice daily (bd) for 2 weeks.
Overall Study STARTED	20	21	13	16	14	14
Overall Study COMPLETED	17	17	13	15	13	13
Overall Study NOT COMPLETED	3	4	0	1	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Clopidogrel Non-responders - Clopidogrel to Ticagrelor Non-responder definition: patients with an absolute difference of less than or equal to 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist. Clopidogrel 600 mg loading dose followed by 75 mg once daily (od) for 2 weeks; switch to ticagrelor 180 mg loading dose followed by 90 mg twice daily (bd) for 2 weeks.	Clopidogrel Non-responders - Ticagrelor to Clopidogrel Non-responder definition: patients with an absolute difference of less than or equal to 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist. Ticagrelor 180 mg loading dose followed by 90 mg twice daily (bd) for 2 weeks; switch to clopidogrel 600 mg loading dose followed by 75 mg once daily (od) for 2 weeks.	Clopidogrel Responders - Clopidogrel to Ticagrelor Responder definition: patients with an absolute difference greater than 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist. Clopidogrel 600 mg loading dose followed by 75 mg once daily (od) for 2 weeks; switch to ticagrelor 180 mg loading dose followed by 90 mg twice daily (bd) for 2 weeks.	Clopidogrel Responders - Ticagrelor to Clopidogrel Responder definition: patients with an absolute difference greater than 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist. Ticagrelor 180 mg loading dose followed by 90 mg twice daily (bd) for 2 weeks; switch to clopidogrel 600 mg loading dose followed by 75 mg once daily (od) for 2 weeks.	Clopidogrel Responders - Ticagrelor to Ticagrelor Responder definition: patients with an absolute difference greater than 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist. Ticagrelor 180 mg loading dose followed by 90 mg twice daily (bd) for 2 weeks; stay on ticagrelor 90 mg twice daily (bd) for 2 weeks.
Overall Study Adverse Event	2	3	0	0	1
Overall Study Developement of discontinuation criteria	0	0	0	1	0
Overall Study Severe Non-compliance to protocol	1	0	0	0	0
Overall Study Other	0	1	1	0	0

Baseline Characteristics

A Study of the Antiplatelet Effects Comparing Ticagrelor (Ticag. - AZD6140) With Clopidogrel (Clop.) Responder and Non-responders

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Clopidogrel Non-responders - Clopidogrel to Ticagrelor n=20 Participants Non-responder definition: patients with an absolute difference of less than or equal to 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist	Clopidogrel Non-responders - Ticagrelor to Clopidogrel n=21 Participants Non-responder definition: patients with an absolute difference of less than or equal to 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist	Clopidogrel Responders - Clopidogrel to Clopidogrel n=13 Participants Responder definition: patients with an absolute difference greater than 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist	Clopidogrel Responders - Clopidogrel to Ticagrelor n=16 Participants Responder definition: patients with an absolute difference greater than 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist	Clopidogrel Responders - Ticagrelor to Clopidogrel n=14 Participants Responder definition: patients with an absolute difference greater than 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist	Clopidogrel Responders - Ticagrelor to Ticagrelor n=14 Participants Responder definition: patients with an absolute difference greater than 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist	Total n=98 Participants Total of all reporting groups
Age Continuous	67.25 year STANDARD_DEVIATION 8.12 • n=5 Participants	64.57 year STANDARD_DEVIATION 6.31 • n=7 Participants	65.46 year STANDARD_DEVIATION 8.68 • n=5 Participants	64.56 year STANDARD_DEVIATION 8.56 • n=4 Participants	63.21 year STANDARD_DEVIATION 9.23 • n=21 Participants	61.57 year STANDARD_DEVIATION 8.22 • n=10 Participants	64.8 year STANDARD_DEVIATION 7.95 • n=115 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	8 Participants n=7 Participants	3 Participants n=5 Participants	2 Participants n=4 Participants	3 Participants n=21 Participants	1 Participants n=10 Participants	22 Participants n=115 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	13 Participants n=7 Participants	10 Participants n=5 Participants	14 Participants n=4 Participants	11 Participants n=21 Participants	13 Participants n=10 Participants	76 Participants n=115 Participants

PRIMARY outcome

Timeframe: Day 14 and Day 28, 4 Hrs Post Dose.

Population: Intent-to-treat analysis set: included patients who were assigned to a cohort, randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data. 32 subjects had IPA data; but 1 subject missing a treatment arm, did not qualify for McNemar's test.

Outcome measures

Outcome measures
Measure	Non-responder: Ticagrelor n=31 Participants patients with an absolute difference of less than or equal to 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist	Non-responder: Clopidogrel n=31 Participants patients with an absolute difference of less than or equal to 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist
Proportion of Clopidogrel Non-responders Who Responded to Clopidogrel or Ticagrelor. - Comparing Ticag. (Day 28 of Clop. to Ticag., and Day 14 of Ticag. to Clop.) Versus Clop. (Day 14 of Clop. to Ticag., and Day 28 of Ticag. to Clop.)	100 Percent of Participants	93.8 Percent of Participants

PRIMARY outcome

Timeframe: Day 14, and day 28, 4 hours post dose

The secondary definition of response to treatment is IPA \>50% post treatment. The response is reported as percentage of participants of each treatment. Please refer to the protocol section for details about the interventions administered. IPA(%)=(PAb-PAt)/PAb\*100. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.

Outcome measures

Outcome measures
Measure	Non-responder: Ticagrelor n=31 Participants patients with an absolute difference of less than or equal to 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist	Non-responder: Clopidogrel n=31 Participants patients with an absolute difference of less than or equal to 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist
Proportion of Clopidogrel Non-responders Who Responded to Clopidogrel or Ticagrelor. - Comparing Ticag. (Day 28 of Clop. to Ticag., and Day 14 of Ticag. to Clop.) Versus Clop. (Day 14 of Clop. to Ticag., and Day 28 of Ticag. to Clop.	81.3 Percent of participants	25.0 Percent of participants

SECONDARY outcome

Timeframe: Day 15, 4 hrs post switching

IPA(%)=(PAb-PAt)/PAb\*100. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition. Please refer to the protocol section for details about the interventions administered.

Outcome measures

Outcome measures
Measure	Non-responder: Ticagrelor n=12 Participants patients with an absolute difference of less than or equal to 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist	Non-responder: Clopidogrel n=10 Participants patients with an absolute difference of less than or equal to 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist
Clopidogrel Responders Final Extent IPA Post Switching Treatment - Comparing Ticagrelor to Ticagrelor Versus Ticagrelor to Clopidogrel on Day 15	66.7 Percent Interval 49.7 to 83.7	65.3 Percent Interval 46.5 to 84.2

SECONDARY outcome

Timeframe: 4 hrs post first dose on day 28

Outcome measures

Outcome measures
Measure	Non-responder: Ticagrelor n=11 Participants patients with an absolute difference of less than or equal to 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist	Non-responder: Clopidogrel n=10 Participants patients with an absolute difference of less than or equal to 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist
Clopidogrel Responders Final Extent IPA Post Switching Treatment - Comparing Ticagrelor to Ticagrelor Versus Ticagrelor to Clopidogrel on Day 28	91.0 Percent Interval 77.1 to 104.9	61.2 Percent Interval 46.4 to 76.0

SECONDARY outcome

Timeframe: Day 15, 4 hrs post switching

Outcome measures

Outcome measures
Measure	Non-responder: Ticagrelor n=14 Participants patients with an absolute difference of less than or equal to 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist	Non-responder: Clopidogrel n=13 Participants patients with an absolute difference of less than or equal to 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist
Clopidogrel Responders Final Extent IPA Post Switching Treatment - Comparing Clopidogrel to Clopidogrel Versus Clopidogrel to Ticagrelor on Day 15	95.0 Percent Interval 87.7 to 102.4	48.5 Percent Interval 40.8 to 56.2

SECONDARY outcome

Timeframe: 4 hrs post first dose on day 28

Outcome measures

Outcome measures
Measure	Non-responder: Ticagrelor n=14 Participants patients with an absolute difference of less than or equal to 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist	Non-responder: Clopidogrel n=13 Participants patients with an absolute difference of less than or equal to 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist
Clopidogrel Responders Final Extent IPA Post Switching Treatment - Comparing Clopidogrel to Clopidogrel Versus Clopidogrel to Ticagrelor on Day 28	77.4 Percent Interval 67.0 to 87.8	60.8 Percent Interval 49.9 to 71.7

Adverse Events

Clopidogrel Non-Responders/Non-Switching Period: Ticagrelor

Serious events: 2 serious events

Other events: 13 other events

Deaths: 0 deaths

Clopidogrel Non-Responders/Non-Switching Period: Clopidogrel

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Clop. Non-Responders/Switching Period:Ticagrelor-Clopidogrel

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Clop. Non-Responders/Switching Period: Clopidogrel-Ticagrelor

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Clop. Responders/Non-Switching Period: Ticagrelor

Serious events: 2 serious events

Other events: 19 other events

Deaths: 0 deaths

Clop. Responders/Non-Switching Period: Clopidogrel

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Clop. Responders/Switching Period: Ticagrelor-Clopidogrel

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Clop. Responders/Switching Period: Clopidogrel-Ticagrelor

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Clopidogrel Non-Responders/Non-Switching Period: Ticagrelor n=39 participants at risk included non-responders exposed to ticagrelor on Day 1-14, Day 16-28.	Clopidogrel Non-Responders/Non-Switching Period: Clopidogrel n=39 participants at risk；n=38 participants at risk included non-responders exposed to clopidogrel on Day 1-14, Day 16-28.	Clop. Non-Responders/Switching Period:Ticagrelor-Clopidogrel n=18 participants at risk included non-responders exposed to ticagrelor switching to clopidogrel on Day 15.	Clop. Non-Responders/Switching Period: Clopidogrel-Ticagrelor n=18 participants at risk included non-responders exposed to clopidogrel switching to ticagrelor on Day 15.	Clop. Responders/Non-Switching Period: Ticagrelor n=44 participants at risk included responders exposed to ticagrelor on Day 1-14, Day 16-28.	Clop. Responders/Non-Switching Period: Clopidogrel n=42 participants at risk included responders exposed to clopidogrel on Day 1-14, Day 16-28.	Clop. Responders/Switching Period: Ticagrelor-Clopidogrel n=13 participants at risk included responders exposed to ticagrelor switching to clopidogrel on Day 15.	Clop. Responders/Switching Period: Clopidogrel-Ticagrelor n=16 participants at risk included responders exposed to clopidogrel switching to ticagrelor on Day 15.
Cardiac disorders Atrial Fibrillation	0.00% 0/39 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	0.00% 0/38 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	0.00% 0/18 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	0.00% 0/18 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	2.3% 1/44 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	0.00% 0/42 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	0.00% 0/13 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	0.00% 0/16 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.
Cardiac disorders Bradycardia	0.00% 0/39 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	0.00% 0/38 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	0.00% 0/18 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	0.00% 0/18 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	2.3% 1/44 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	0.00% 0/42 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	0.00% 0/13 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	0.00% 0/16 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.
Cardiac disorders Myocardial Infarction	2.6% 1/39 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	0.00% 0/38 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	0.00% 0/18 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	0.00% 0/18 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	0.00% 0/44 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	0.00% 0/42 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	0.00% 0/13 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	0.00% 0/16 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.
Cardiac disorders Ventricular Extrasystoles	0.00% 0/39 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	0.00% 0/38 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	0.00% 0/18 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	0.00% 0/18 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	2.3% 1/44 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	0.00% 0/42 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	0.00% 0/13 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	0.00% 0/16 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.
Vascular disorders Hypotension	2.6% 1/39 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	0.00% 0/38 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	0.00% 0/18 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	0.00% 0/18 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	0.00% 0/44 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	0.00% 0/42 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	0.00% 0/13 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	0.00% 0/16 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.

Other adverse events

Other adverse events
Measure	Clopidogrel Non-Responders/Non-Switching Period: Ticagrelor n=39 participants at risk included non-responders exposed to ticagrelor on Day 1-14, Day 16-28.	Clopidogrel Non-Responders/Non-Switching Period: Clopidogrel n=39 participants at risk；n=38 participants at risk included non-responders exposed to clopidogrel on Day 1-14, Day 16-28.	Clop. Non-Responders/Switching Period:Ticagrelor-Clopidogrel n=18 participants at risk included non-responders exposed to ticagrelor switching to clopidogrel on Day 15.	Clop. Non-Responders/Switching Period: Clopidogrel-Ticagrelor n=18 participants at risk included non-responders exposed to clopidogrel switching to ticagrelor on Day 15.	Clop. Responders/Non-Switching Period: Ticagrelor n=44 participants at risk included responders exposed to ticagrelor on Day 1-14, Day 16-28.	Clop. Responders/Non-Switching Period: Clopidogrel n=42 participants at risk included responders exposed to clopidogrel on Day 1-14, Day 16-28.	Clop. Responders/Switching Period: Ticagrelor-Clopidogrel n=13 participants at risk included responders exposed to ticagrelor switching to clopidogrel on Day 15.	Clop. Responders/Switching Period: Clopidogrel-Ticagrelor n=16 participants at risk included responders exposed to clopidogrel switching to ticagrelor on Day 15.
Gastrointestinal disorders DYSPEPSIA	0.00% 0/39 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	0.00% 0/38 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	0.00% 0/18 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	0.00% 0/18 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	2.3% 1/44 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	9.5% 4/42 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	0.00% 0/13 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	0.00% 0/16 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.
Gastrointestinal disorders NAUSEA	0.00% 0/39 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	2.6% 1/38 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	0.00% 0/18 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	0.00% 0/18 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	0.00% 0/44 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	9.5% 4/42 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	0.00% 0/13 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	0.00% 0/16 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.
Gastrointestinal disorders DIARRHOEA	5.1% 2/39 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	2.6% 1/38 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	0.00% 0/18 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	0.00% 0/18 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	2.3% 1/44 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	4.8% 2/42 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	0.00% 0/13 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	0.00% 0/16 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.
General disorders FATIGUE	0.00% 0/39 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	2.6% 1/38 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	0.00% 0/18 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	0.00% 0/18 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	2.3% 1/44 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	4.8% 2/42 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	7.7% 1/13 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	0.00% 0/16 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.
General disorders VESSEL PUNCTURE SITE HAEMATOMA	0.00% 0/39 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	0.00% 0/38 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	0.00% 0/18 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	5.6% 1/18 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	4.5% 2/44 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	4.8% 2/42 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	0.00% 0/13 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	0.00% 0/16 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.
General disorders CHEST DISCOMFORT	0.00% 0/39 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	0.00% 0/38 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	5.6% 1/18 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	0.00% 0/18 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	0.00% 0/44 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	0.00% 0/42 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	0.00% 0/13 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	0.00% 0/16 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.
Injury, poisoning and procedural complications CONTUSION	0.00% 0/39 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	0.00% 0/38 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	0.00% 0/18 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	0.00% 0/18 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	6.8% 3/44 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	0.00% 0/42 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	0.00% 0/13 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	0.00% 0/16 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.
Injury, poisoning and procedural complications TRAUMATIC HAEMATOMA	0.00% 0/39 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	5.3% 2/38 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	0.00% 0/18 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	0.00% 0/18 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	4.5% 2/44 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	0.00% 0/42 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	0.00% 0/13 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	0.00% 0/16 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.
Musculoskeletal and connective tissue disorders ARTHRALGIA	0.00% 0/39 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	0.00% 0/38 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	0.00% 0/18 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	0.00% 0/18 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	0.00% 0/44 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	2.4% 1/42 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	7.7% 1/13 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	0.00% 0/16 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.
Musculoskeletal and connective tissue disorders MYALGIA	0.00% 0/39 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	2.6% 1/38 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	0.00% 0/18 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	0.00% 0/18 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	0.00% 0/44 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	0.00% 0/42 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	7.7% 1/13 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	0.00% 0/16 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.
Nervous system disorders DIZZINESS	2.6% 1/39 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	7.9% 3/38 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	0.00% 0/18 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	11.1% 2/18 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	2.3% 1/44 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	2.4% 1/42 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	0.00% 0/13 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	0.00% 0/16 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.
Nervous system disorders HEADACHE	5.1% 2/39 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	2.6% 1/38 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	0.00% 0/18 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	0.00% 0/18 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	0.00% 0/44 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	2.4% 1/42 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	0.00% 0/13 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	0.00% 0/16 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.
Nervous system disorders PARAESTHESIA	0.00% 0/39 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	5.3% 2/38 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	0.00% 0/18 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	0.00% 0/18 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	2.3% 1/44 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	0.00% 0/42 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	0.00% 0/13 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	0.00% 0/16 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.
Nervous system disorders RESTLESS LEGS SYNDROME	0.00% 0/39 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	2.6% 1/38 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	0.00% 0/18 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	5.6% 1/18 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	0.00% 0/44 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	0.00% 0/42 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	0.00% 0/13 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	0.00% 0/16 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.
Respiratory, thoracic and mediastinal disorders DYSPNOEA	17.9% 7/39 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	7.9% 3/38 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	5.6% 1/18 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	11.1% 2/18 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	13.6% 6/44 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	0.00% 0/42 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	0.00% 0/13 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	0.00% 0/16 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.
Respiratory, thoracic and mediastinal disorders EPISTAXIS	0.00% 0/39 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	0.00% 0/38 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	0.00% 0/18 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	0.00% 0/18 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	6.8% 3/44 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	0.00% 0/42 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	0.00% 0/13 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	0.00% 0/16 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.
Skin and subcutaneous tissue disorders INCREASED TENDENCY TO BRUISE	7.7% 3/39 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	2.6% 1/38 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	0.00% 0/18 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	0.00% 0/18 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	4.5% 2/44 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	4.8% 2/42 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	0.00% 0/13 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.	6.2% 1/16 • Switching Period - first 24 hrs (Day 15), patients switched study medication (from clop. to ticag. or vice versa). Non-Switching Period - Day 1-14 and Day 16-28. Analysis included all randomized subjects.

Additional Information

Gerard Lynch

AstraZeneca

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee An Investigator agrees to provide a copy of the publication to AZ for review at least 60 days in advance of submission for publication. Investigators in multicenter (MC) studies agree to postpone MC publications until the earlier of the date of the first AZ-authorized MC publication or a period up to 18 months from study completion at all sites.
Publication restrictions are in place

Restriction type: OTHER