Trial Outcomes & Findings for A Pharmacodynamic Study With Ticagrelor in Hispanic Patients (NCT NCT01523366)

Last Updated: 2014-08-18

Results Overview

Participants with low (\<150) baseline PRU values (indicating an incomplete washout from anti-platelet therapy) were excluded during the period corresponding to the low baseline value

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

53 participants

Primary outcome timeframe

At 2 hours after the loading dose

Results posted on

2014-08-18

Participant Flow

Patients recruited from 6 centers in the United States from April 2012 until May 2013.

53 patients screened; 40 patients randomized; 38 patients completed the study (7, 8, or 9 days of both treatment sequences), and 39 completed follow-up.

Participant milestones

Participant milestones
Measure	Ticagrelor (Period 1) Then Clopidogrel (Period 2) Sequence Ticagrelor 180 milligrams (mg) loading dose followed by 90 mg twice daily (bd) for 7,8 or 9 days (Period 1), and then clopidogrel 600 mg loading dose followed by 75 mg once daily (od) for 7, 8 or 9 days (Period 2).	Clopidogrel (Period 1) Then Ticagrelor (Period 2) Sequence Clopidogrel 600 mg loading dose followed by 75 mg od for 7, 8 or 9 days (Period 1), then ticagrelor 180 mg loading dose followed by 90 mg bd for 7,8 or 9 days (Period 2)
Treatment Period 1 STARTED	20	20
Treatment Period 1 COMPLETED	19	20
Treatment Period 1 NOT COMPLETED	1	0
Washout Period - 10-14 Days STARTED	19	20
Washout Period - 10-14 Days COMPLETED	19	20
Washout Period - 10-14 Days NOT COMPLETED	0	0
Treatment Period 2 STARTED	19	20
Treatment Period 2 COMPLETED	18	20
Treatment Period 2 NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Ticagrelor (Period 1) Then Clopidogrel (Period 2) Sequence Ticagrelor 180 milligrams (mg) loading dose followed by 90 mg twice daily (bd) for 7,8 or 9 days (Period 1), and then clopidogrel 600 mg loading dose followed by 75 mg once daily (od) for 7, 8 or 9 days (Period 2).	Clopidogrel (Period 1) Then Ticagrelor (Period 2) Sequence Clopidogrel 600 mg loading dose followed by 75 mg od for 7, 8 or 9 days (Period 1), then ticagrelor 180 mg loading dose followed by 90 mg bd for 7,8 or 9 days (Period 2)
Treatment Period 1 Withdrawal by Subject	1	0
Treatment Period 2 Not completed at least 7 days treatment	1	0

Baseline Characteristics

A Pharmacodynamic Study With Ticagrelor in Hispanic Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ticagrelor (Period 1) Then Clopidogrel (Period 2) Sequence n=20 Participants Ticagrelor 180 milligrams (mg) loading dose followed by 90 mg twice daily (bd) for 7,8 or 9 days (Period 1), and then clopidogrel 600 mg loading dose followed by 75 mg once daily (od) for 7, 8 or 9 days (Period 2).	Clopidogrel (Period 1) Then Ticagrelor (Period 2) Sequence n=20 Participants Clopidogrel 600 mg loading dose followed by 75 mg od for 7, 8 or 9 days (Period 1), then ticagrelor 180 mg loading dose followed by 90 mg bd for 7,8 or 9 days (Period 2)	Total n=40 Participants Total of all reporting groups
Age, Customized <18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Customized Between 18 and 65 years	10 Participants n=5 Participants	12 Participants n=7 Participants	22 Participants n=5 Participants
Age, Customized >=65 years	10 Participants n=5 Participants	8 Participants n=7 Participants	18 Participants n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	14 Participants n=7 Participants	28 Participants n=5 Participants
Race/Ethnicity, Customized White	17 Participants n=5 Participants	18 Participants n=7 Participants	35 Participants n=5 Participants
Race/Ethnicity, Customized Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	20 Participants n=5 Participants	20 Participants n=7 Participants	40 Participants n=5 Participants
Region of Enrollment United States	20 Participants n=5 Participants	20 Participants n=7 Participants	40 Participants n=5 Participants

PRIMARY outcome

Timeframe: At 2 hours after the loading dose

Population: Pharmacodynamic (PD) Analysis Set

Participants with low (\<150) baseline PRU values (indicating an incomplete washout from anti-platelet therapy) were excluded during the period corresponding to the low baseline value

Outcome measures

Outcome measures
Measure	Ticagrelor Arm n=37 Participants Ticagrelor 180 mg loading dose followed by 90 mg bd for 7,8 or 9 days.	Clopidogrel Arm n=34 Participants Clopidogrel 600 mg loading dose followed by 75 mg od for 7, 8 or 9 days.
Inhibition of the P2Y12 Receptor as Measured by P2Y12 Reactions Units (PRU) From VerifyNow™ (a Platelet Function Test Developed by Accumetrics) at 2 Hours After Loading Dose	34.2 PRU Interval 12.4 to 55.9	201.4 PRU Interval 178.7 to 224.1

SECONDARY outcome

Timeframe: At 0.5 and 8 hours after the loading dose

Population: PD Analysis Set

Participants with low (\<150) baseline PRU values (indicating an incomplete washout from anti-platelet therapy) were excluded during the period corresponding to the low baseline value

Outcome measures

Outcome measures
Measure	Ticagrelor Arm n=38 Participants Ticagrelor 180 mg loading dose followed by 90 mg bd for 7,8 or 9 days.	Clopidogrel Arm n=34 Participants Clopidogrel 600 mg loading dose followed by 75 mg od for 7, 8 or 9 days.
Inhibition of the P2Y12 Receptor as Measured by PRU From VerifyNow™ at 0.5 and 8 Hours After Loading Dose 0.5 hours	134.6 PRU Interval 105.1 to 164.1	269.8 PRU Interval 238.7 to 300.8
Inhibition of the P2Y12 Receptor as Measured by PRU From VerifyNow™ at 0.5 and 8 Hours After Loading Dose 8 hours	34.0 PRU Interval 9.2 to 58.8	202.8 PRU Interval 176.6 to 229.0

SECONDARY outcome

Timeframe: At 2 hours and 8 hours on Day 7 after multiple doses, and at the end of dosing interval on Day 8

Population: PD Analysis Set

The end of dosing interval was approximately 12 hours after the last evening dose of ticagrelor and approximately 24 hours after the last morning dose of clopidogrel. Participants with low (\<150) baseline PRU values (indicating an incomplete washout from anti-platelet therapy) were excluded during the period corresponding to the low baseline value

Outcome measures

Outcome measures
Measure	Ticagrelor Arm n=37 Participants Ticagrelor 180 mg loading dose followed by 90 mg bd for 7,8 or 9 days.	Clopidogrel Arm n=34 Participants Clopidogrel 600 mg loading dose followed by 75 mg od for 7, 8 or 9 days.
Inhibition of the P2Y12 Receptor as Measured by PRU From VerifyNow™ at 2 and 8 Hours on Day 7 After Multiple Doses and at End of Dosing Interval on Day 8 2 hours on day 7	28.5 PRU Interval 8.0 to 49.0	179.0 PRU Interval 157.7 to 200.3
Inhibition of the P2Y12 Receptor as Measured by PRU From VerifyNow™ at 2 and 8 Hours on Day 7 After Multiple Doses and at End of Dosing Interval on Day 8 8 hours on Day 7 -ticagrelor N=36 clopidogrel N=33	38.7 PRU Interval 17.2 to 60.3	178.9 PRU Interval 156.5 to 201.4
Inhibition of the P2Y12 Receptor as Measured by PRU From VerifyNow™ at 2 and 8 Hours on Day 7 After Multiple Doses and at End of Dosing Interval on Day 8 End of Dosing Interval on Day 8 - N's per 8 hours	51.5 PRU Interval 29.8 to 73.1	182.1 PRU Interval 159.5 to 204.7

SECONDARY outcome

Timeframe: Predose, 0.5, 2, 8 hours from loading dose; 0, 2, 8 and 12 hours from last dose

Population: Pharmacokinetic (PK) Analysis Set, defined as all participants for whom at least one valid PK reading was available

The standard deviation (SD) is a statistic using the log-transformed data and is not the geometric SD.

Outcome measures

Outcome measures
Measure	Ticagrelor Arm n=18 Participants Ticagrelor 180 mg loading dose followed by 90 mg bd for 7,8 or 9 days.	Clopidogrel Arm n=19 Participants Clopidogrel 600 mg loading dose followed by 75 mg od for 7, 8 or 9 days.
Ticagrelor Plasma Concentrations After the Loading and Maintenance Doses Baseline (0 hours - pre-dose)	1.2 ng/mL Standard Deviation 7.5	1.1 ng/mL Standard Deviation 1.8
Ticagrelor Plasma Concentrations After the Loading and Maintenance Doses 0,.5 hours after the loading dose	206.7 ng/mL Standard Deviation 413.1	118.6 ng/mL Standard Deviation 352.0
Ticagrelor Plasma Concentrations After the Loading and Maintenance Doses 2 hours after the loading dose - Period 2 N=18	665.4 ng/mL Standard Deviation 566.2	758.5 ng/mL Standard Deviation 716.6
Ticagrelor Plasma Concentrations After the Loading and Maintenance Doses 8 hours after the loading dose	376.9 ng/mL Standard Deviation 378.8	479.6 ng/mL Standard Deviation 210.7
Ticagrelor Plasma Concentrations After the Loading and Maintenance Doses 0 hours after multiple doses	248.8 ng/mL Standard Deviation 238.9	220.1 ng/mL Standard Deviation 295.8
Ticagrelor Plasma Concentrations After the Loading and Maintenance Doses 2 hours after multiple doses	609.3 ng/mL Standard Deviation 271.3	466.5 ng/mL Standard Deviation 534.5
Ticagrelor Plasma Concentrations After the Loading and Maintenance Doses 8 hours after multiple doses	340.4 ng/mL Standard Deviation 283.8	305.2 ng/mL Standard Deviation 301.6
Ticagrelor Plasma Concentrations After the Loading and Maintenance Doses End of dosing interval on Day 8 - Period 1 N=17	283.3 ng/mL Standard Deviation 438.1	200.7 ng/mL Standard Deviation 268.4

SECONDARY outcome

Timeframe: Predose, 0.5, 2, 8 hours from loading dose; 0, 2, 8 and 12 hours from last dose

Population: PK Analysis Set

The SD is a statistic using the log-transformed data and is not the geometric SD.

Outcome measures

Outcome measures
Measure	Ticagrelor Arm n=18 Participants Ticagrelor 180 mg loading dose followed by 90 mg bd for 7,8 or 9 days.	Clopidogrel Arm n=19 Participants Clopidogrel 600 mg loading dose followed by 75 mg od for 7, 8 or 9 days.
AR-C124910XX (an Active Metabolite of Ticagrelor) Plasma Concentrations After the Loading and Maintenance Doses 8 hours after multiple doses	132.8 ng/mL Standard Deviation 61.9	83.5 ng/mL Standard Deviation 71.4
AR-C124910XX (an Active Metabolite of Ticagrelor) Plasma Concentrations After the Loading and Maintenance Doses Baseline (0 hours - pre-dose)	1.1 ng/mL Standard Deviation 2.3	1.0 ng/mL Standard Deviation 0.0
AR-C124910XX (an Active Metabolite of Ticagrelor) Plasma Concentrations After the Loading and Maintenance Doses 0,.5 hours after the loading dose	13.6 ng/mL Standard Deviation 66.3	9.3 ng/mL Standard Deviation 26.9
AR-C124910XX (an Active Metabolite of Ticagrelor) Plasma Concentrations After the Loading and Maintenance Doses 2 hours after the loading dose - Period 2 N=18	153.2 ng/mL Standard Deviation 128.6	170.8 ng/mL Standard Deviation 156.5
AR-C124910XX (an Active Metabolite of Ticagrelor) Plasma Concentrations After the Loading and Maintenance Doses 8 hours after the loading dose	113.8 ng/mL Standard Deviation 54.6	97.7 ng/mL Standard Deviation 61.9
AR-C124910XX (an Active Metabolite of Ticagrelor) Plasma Concentrations After the Loading and Maintenance Doses 0 hours after multiple doses	113.3 ng/mL Standard Deviation 102.1	62.7 ng/mL Standard Deviation 76.7
AR-C124910XX (an Active Metabolite of Ticagrelor) Plasma Concentrations After the Loading and Maintenance Doses 2 hours after multiple doses	183.4 ng/mL Standard Deviation 120.8	97.4 ng/mL Standard Deviation 147.9
AR-C124910XX (an Active Metabolite of Ticagrelor) Plasma Concentrations After the Loading and Maintenance Doses End of dosing interval on Day 8 - Period 1 N=17	124.8 ng/mL Standard Deviation 56.6	57.7 ng/mL Standard Deviation 83.5

Adverse Events

Ticagrelor Arm

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Clopidogrel Arm

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Tomas LG Andersson, MD, PhD

AstraZeneca

Phone: 1-800-236-9933

Email: [email protected]

Results disclosure agreements

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

Restriction type: OTHER

Measure	Ticagrelor Arm n=40 participants at risk Ticagrelor 180 mg loading dose followed by 90 mg bd for 7,8 or 9 days.	Clopidogrel Arm n=39 participants at risk Clopidogrel 600 mg loading dose followed by 75 mg od for 7, 8 or 9 days.
Gastrointestinal disorders Diarrhea	2.5% 1/40 • Adverse events were collected from the time of signature of the informed consent throughout the treatment period including the follow up visit (approximately 11 weeks for each participant). Adverse events were solicited at each scheduled visit and could be reported by the participant at any time during the study. When summarizing Treatment Period 1 and Treatment Period 2 totals, each participant was counted only once for an individual adverse event, regardless of whether it occurred on ticagrelor, clopidogrel or both.	0.00% 0/39 • Adverse events were collected from the time of signature of the informed consent throughout the treatment period including the follow up visit (approximately 11 weeks for each participant). Adverse events were solicited at each scheduled visit and could be reported by the participant at any time during the study. When summarizing Treatment Period 1 and Treatment Period 2 totals, each participant was counted only once for an individual adverse event, regardless of whether it occurred on ticagrelor, clopidogrel or both.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/40 • Adverse events were collected from the time of signature of the informed consent throughout the treatment period including the follow up visit (approximately 11 weeks for each participant). Adverse events were solicited at each scheduled visit and could be reported by the participant at any time during the study. When summarizing Treatment Period 1 and Treatment Period 2 totals, each participant was counted only once for an individual adverse event, regardless of whether it occurred on ticagrelor, clopidogrel or both.	2.6% 1/39 • Adverse events were collected from the time of signature of the informed consent throughout the treatment period including the follow up visit (approximately 11 weeks for each participant). Adverse events were solicited at each scheduled visit and could be reported by the participant at any time during the study. When summarizing Treatment Period 1 and Treatment Period 2 totals, each participant was counted only once for an individual adverse event, regardless of whether it occurred on ticagrelor, clopidogrel or both.
Respiratory, thoracic and mediastinal disorders Dyspnea	5.0% 2/40 • Adverse events were collected from the time of signature of the informed consent throughout the treatment period including the follow up visit (approximately 11 weeks for each participant). Adverse events were solicited at each scheduled visit and could be reported by the participant at any time during the study. When summarizing Treatment Period 1 and Treatment Period 2 totals, each participant was counted only once for an individual adverse event, regardless of whether it occurred on ticagrelor, clopidogrel or both.	0.00% 0/39 • Adverse events were collected from the time of signature of the informed consent throughout the treatment period including the follow up visit (approximately 11 weeks for each participant). Adverse events were solicited at each scheduled visit and could be reported by the participant at any time during the study. When summarizing Treatment Period 1 and Treatment Period 2 totals, each participant was counted only once for an individual adverse event, regardless of whether it occurred on ticagrelor, clopidogrel or both.
Respiratory, thoracic and mediastinal disorders Oropharyngeal discomfort	2.5% 1/40 • Adverse events were collected from the time of signature of the informed consent throughout the treatment period including the follow up visit (approximately 11 weeks for each participant). Adverse events were solicited at each scheduled visit and could be reported by the participant at any time during the study. When summarizing Treatment Period 1 and Treatment Period 2 totals, each participant was counted only once for an individual adverse event, regardless of whether it occurred on ticagrelor, clopidogrel or both.	0.00% 0/39 • Adverse events were collected from the time of signature of the informed consent throughout the treatment period including the follow up visit (approximately 11 weeks for each participant). Adverse events were solicited at each scheduled visit and could be reported by the participant at any time during the study. When summarizing Treatment Period 1 and Treatment Period 2 totals, each participant was counted only once for an individual adverse event, regardless of whether it occurred on ticagrelor, clopidogrel or both.
General disorders Malaise	2.5% 1/40 • Adverse events were collected from the time of signature of the informed consent throughout the treatment period including the follow up visit (approximately 11 weeks for each participant). Adverse events were solicited at each scheduled visit and could be reported by the participant at any time during the study. When summarizing Treatment Period 1 and Treatment Period 2 totals, each participant was counted only once for an individual adverse event, regardless of whether it occurred on ticagrelor, clopidogrel or both.	0.00% 0/39 • Adverse events were collected from the time of signature of the informed consent throughout the treatment period including the follow up visit (approximately 11 weeks for each participant). Adverse events were solicited at each scheduled visit and could be reported by the participant at any time during the study. When summarizing Treatment Period 1 and Treatment Period 2 totals, each participant was counted only once for an individual adverse event, regardless of whether it occurred on ticagrelor, clopidogrel or both.
Investigations Heart rate irregular	2.5% 1/40 • Adverse events were collected from the time of signature of the informed consent throughout the treatment period including the follow up visit (approximately 11 weeks for each participant). Adverse events were solicited at each scheduled visit and could be reported by the participant at any time during the study. When summarizing Treatment Period 1 and Treatment Period 2 totals, each participant was counted only once for an individual adverse event, regardless of whether it occurred on ticagrelor, clopidogrel or both.	0.00% 0/39 • Adverse events were collected from the time of signature of the informed consent throughout the treatment period including the follow up visit (approximately 11 weeks for each participant). Adverse events were solicited at each scheduled visit and could be reported by the participant at any time during the study. When summarizing Treatment Period 1 and Treatment Period 2 totals, each participant was counted only once for an individual adverse event, regardless of whether it occurred on ticagrelor, clopidogrel or both.
Investigations Heart rate increased	2.5% 1/40 • Adverse events were collected from the time of signature of the informed consent throughout the treatment period including the follow up visit (approximately 11 weeks for each participant). Adverse events were solicited at each scheduled visit and could be reported by the participant at any time during the study. When summarizing Treatment Period 1 and Treatment Period 2 totals, each participant was counted only once for an individual adverse event, regardless of whether it occurred on ticagrelor, clopidogrel or both.	0.00% 0/39 • Adverse events were collected from the time of signature of the informed consent throughout the treatment period including the follow up visit (approximately 11 weeks for each participant). Adverse events were solicited at each scheduled visit and could be reported by the participant at any time during the study. When summarizing Treatment Period 1 and Treatment Period 2 totals, each participant was counted only once for an individual adverse event, regardless of whether it occurred on ticagrelor, clopidogrel or both.
Nervous system disorders Headache	2.5% 1/40 • Adverse events were collected from the time of signature of the informed consent throughout the treatment period including the follow up visit (approximately 11 weeks for each participant). Adverse events were solicited at each scheduled visit and could be reported by the participant at any time during the study. When summarizing Treatment Period 1 and Treatment Period 2 totals, each participant was counted only once for an individual adverse event, regardless of whether it occurred on ticagrelor, clopidogrel or both.	5.1% 2/39 • Adverse events were collected from the time of signature of the informed consent throughout the treatment period including the follow up visit (approximately 11 weeks for each participant). Adverse events were solicited at each scheduled visit and could be reported by the participant at any time during the study. When summarizing Treatment Period 1 and Treatment Period 2 totals, each participant was counted only once for an individual adverse event, regardless of whether it occurred on ticagrelor, clopidogrel or both.
Nervous system disorders Dizziness	2.5% 1/40 • Adverse events were collected from the time of signature of the informed consent throughout the treatment period including the follow up visit (approximately 11 weeks for each participant). Adverse events were solicited at each scheduled visit and could be reported by the participant at any time during the study. When summarizing Treatment Period 1 and Treatment Period 2 totals, each participant was counted only once for an individual adverse event, regardless of whether it occurred on ticagrelor, clopidogrel or both.	0.00% 0/39 • Adverse events were collected from the time of signature of the informed consent throughout the treatment period including the follow up visit (approximately 11 weeks for each participant). Adverse events were solicited at each scheduled visit and could be reported by the participant at any time during the study. When summarizing Treatment Period 1 and Treatment Period 2 totals, each participant was counted only once for an individual adverse event, regardless of whether it occurred on ticagrelor, clopidogrel or both.
Nervous system disorders Dysgeusia	2.5% 1/40 • Adverse events were collected from the time of signature of the informed consent throughout the treatment period including the follow up visit (approximately 11 weeks for each participant). Adverse events were solicited at each scheduled visit and could be reported by the participant at any time during the study. When summarizing Treatment Period 1 and Treatment Period 2 totals, each participant was counted only once for an individual adverse event, regardless of whether it occurred on ticagrelor, clopidogrel or both.	0.00% 0/39 • Adverse events were collected from the time of signature of the informed consent throughout the treatment period including the follow up visit (approximately 11 weeks for each participant). Adverse events were solicited at each scheduled visit and could be reported by the participant at any time during the study. When summarizing Treatment Period 1 and Treatment Period 2 totals, each participant was counted only once for an individual adverse event, regardless of whether it occurred on ticagrelor, clopidogrel or both.
Nervous system disorders Burning Sensation	2.5% 1/40 • Adverse events were collected from the time of signature of the informed consent throughout the treatment period including the follow up visit (approximately 11 weeks for each participant). Adverse events were solicited at each scheduled visit and could be reported by the participant at any time during the study. When summarizing Treatment Period 1 and Treatment Period 2 totals, each participant was counted only once for an individual adverse event, regardless of whether it occurred on ticagrelor, clopidogrel or both.	0.00% 0/39 • Adverse events were collected from the time of signature of the informed consent throughout the treatment period including the follow up visit (approximately 11 weeks for each participant). Adverse events were solicited at each scheduled visit and could be reported by the participant at any time during the study. When summarizing Treatment Period 1 and Treatment Period 2 totals, each participant was counted only once for an individual adverse event, regardless of whether it occurred on ticagrelor, clopidogrel or both.
Injury, poisoning and procedural complications Fall	0.00% 0/40 • Adverse events were collected from the time of signature of the informed consent throughout the treatment period including the follow up visit (approximately 11 weeks for each participant). Adverse events were solicited at each scheduled visit and could be reported by the participant at any time during the study. When summarizing Treatment Period 1 and Treatment Period 2 totals, each participant was counted only once for an individual adverse event, regardless of whether it occurred on ticagrelor, clopidogrel or both.	5.1% 2/39 • Adverse events were collected from the time of signature of the informed consent throughout the treatment period including the follow up visit (approximately 11 weeks for each participant). Adverse events were solicited at each scheduled visit and could be reported by the participant at any time during the study. When summarizing Treatment Period 1 and Treatment Period 2 totals, each participant was counted only once for an individual adverse event, regardless of whether it occurred on ticagrelor, clopidogrel or both.
Injury, poisoning and procedural complications Rib fracture	0.00% 0/40 • Adverse events were collected from the time of signature of the informed consent throughout the treatment period including the follow up visit (approximately 11 weeks for each participant). Adverse events were solicited at each scheduled visit and could be reported by the participant at any time during the study. When summarizing Treatment Period 1 and Treatment Period 2 totals, each participant was counted only once for an individual adverse event, regardless of whether it occurred on ticagrelor, clopidogrel or both.	2.6% 1/39 • Adverse events were collected from the time of signature of the informed consent throughout the treatment period including the follow up visit (approximately 11 weeks for each participant). Adverse events were solicited at each scheduled visit and could be reported by the participant at any time during the study. When summarizing Treatment Period 1 and Treatment Period 2 totals, each participant was counted only once for an individual adverse event, regardless of whether it occurred on ticagrelor, clopidogrel or both.
Infections and infestations Nasopharyngitis	0.00% 0/40 • Adverse events were collected from the time of signature of the informed consent throughout the treatment period including the follow up visit (approximately 11 weeks for each participant). Adverse events were solicited at each scheduled visit and could be reported by the participant at any time during the study. When summarizing Treatment Period 1 and Treatment Period 2 totals, each participant was counted only once for an individual adverse event, regardless of whether it occurred on ticagrelor, clopidogrel or both.	2.6% 1/39 • Adverse events were collected from the time of signature of the informed consent throughout the treatment period including the follow up visit (approximately 11 weeks for each participant). Adverse events were solicited at each scheduled visit and could be reported by the participant at any time during the study. When summarizing Treatment Period 1 and Treatment Period 2 totals, each participant was counted only once for an individual adverse event, regardless of whether it occurred on ticagrelor, clopidogrel or both.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	2.5% 1/40 • Adverse events were collected from the time of signature of the informed consent throughout the treatment period including the follow up visit (approximately 11 weeks for each participant). Adverse events were solicited at each scheduled visit and could be reported by the participant at any time during the study. When summarizing Treatment Period 1 and Treatment Period 2 totals, each participant was counted only once for an individual adverse event, regardless of whether it occurred on ticagrelor, clopidogrel or both.	0.00% 0/39 • Adverse events were collected from the time of signature of the informed consent throughout the treatment period including the follow up visit (approximately 11 weeks for each participant). Adverse events were solicited at each scheduled visit and could be reported by the participant at any time during the study. When summarizing Treatment Period 1 and Treatment Period 2 totals, each participant was counted only once for an individual adverse event, regardless of whether it occurred on ticagrelor, clopidogrel or both.