Trial Outcomes & Findings for Ad Hoc Percutaneous Coronary Intervention Study in Acute Coronary Syndrome Patients (NCT NCT01603082)

NCT ID: NCT01603082

Last Updated: 2015-12-11

Results Overview

Participants with low (\<150) baseline PRU values were excluded.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 343 participants
• Primary outcome timeframe: 2 hours after the loading dose
• Results posted on: 2015-12-11

Participant Flow

Participants recruited from 15 actively participating sites in the United States of America, from July 2012 until June 2014.

Overall, 343 participants were screened; 102 met inclusion/exclusion criteria, 100 were randomized. 96 participants completed treatment and 97 participants completed the study.

Participant milestones

Measure	Ticagrelor 180 mg loading dose after diagnostic angiography, followed by 90 mg after 12 hours (± 1 hour), with concomitant acetylysalicylic acid (160 mg to 500mg loading dose followed by a daily maintenance dose of 75 mg to 100 mg)	Clopidogrel 600 mg loading dose after diagnostic angiography, with concomitant acetylysalicylic acid (160 mg to 500mg loading dose followed by a daily maintenance dose of 75 mg to 100 mg)
Overall Study STARTED	51	49
Overall Study COMPLETED	49	48
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Measure	Ticagrelor 180 mg loading dose after diagnostic angiography, followed by 90 mg after 12 hours (± 1 hour), with concomitant acetylysalicylic acid (160 mg to 500mg loading dose followed by a daily maintenance dose of 75 mg to 100 mg)	Clopidogrel 600 mg loading dose after diagnostic angiography, with concomitant acetylysalicylic acid (160 mg to 500mg loading dose followed by a daily maintenance dose of 75 mg to 100 mg)
Overall Study Adverse Event	0	1
Overall Study Withdrawal by Subject	1	0
Overall Study Failed inclusion criterion after dosed	1	0

Baseline Characteristics

Ad Hoc Percutaneous Coronary Intervention Study in Acute Coronary Syndrome Patients

Baseline characteristics by cohort

Measure	Ticagrelor n=51 Participants 180 mg loading dose after diagnostic angiography, followed by 90 mg after 12 hours (± 1 hour), with concomitant acetylysalicylic acid (160 mg to 500mg loading dose followed by a daily maintenance dose of 75 mg to 100 mg)	Clopidogrel n=49 Participants 600 mg loading dose after diagnostic angiography, with concomitant acetylysalicylic acid (160 mg to 500mg loading dose followed by a daily maintenance dose of 75 mg to 100 mg)	Total n=100 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	36 Participants n=93 Participants	30 Participants n=4 Participants	66 Participants n=27 Participants
Age, Categorical >=65 years	15 Participants n=93 Participants	19 Participants n=4 Participants	34 Participants n=27 Participants
Sex: Female, Male Female	17 Participants n=93 Participants	13 Participants n=4 Participants	30 Participants n=27 Participants
Sex: Female, Male Male	34 Participants n=93 Participants	36 Participants n=4 Participants	70 Participants n=27 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Race/Ethnicity, Customized Asian	1 Participants n=93 Participants	2 Participants n=4 Participants	3 Participants n=27 Participants
Race/Ethnicity, Customized Black or African American	11 Participants n=93 Participants	11 Participants n=4 Participants	22 Participants n=27 Participants
Race/Ethnicity, Customized White	33 Participants n=93 Participants	33 Participants n=4 Participants	66 Participants n=27 Participants
Race/Ethnicity, Customized Missing values	7 Participants n=93 Participants	7 Participants n=4 Participants	14 Participants n=27 Participants
Race/Ethnicity, Customized Hispanic or Latino	5 Participants n=93 Participants	1 Participants n=4 Participants	6 Participants n=27 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	11 Participants n=93 Participants	14 Participants n=4 Participants	25 Participants n=27 Participants
Race/Ethnicity, Customized Not Reported	28 Participants n=93 Participants	27 Participants n=4 Participants	55 Participants n=27 Participants
Region of Enrollment United States	51 Participants n=93 Participants	49 Participants n=4 Participants	100 Participants n=27 Participants

PRIMARY outcome

Timeframe: 2 hours after the loading dose

Population: Pharmacodynamic (PD) Analysis Set (N=93; 46 on ticagrelor, 47 on clopidogrel) - included all participants with PD data and without a major protocol deviation thought to significantly affect the PD of ticagrelor or clopidogrel. Participants in the PD Analysis Set with low (\<150) baseline PRU values were excluded from the analyses.

Participants with low (<150) baseline PRU values were excluded.

Outcome measures

Measure	Ticagrelor n=45 Participants 180 mg loading dose after diagnostic angiography, followed by 90 mg after 12 hours (± 1 hour), with concomitant acetylysalicylic acid (160 mg to 500mg loading dose followed by a daily maintenance dose of 75 mg to 100 mg)	Clopidogrel n=46 Participants 600 mg loading dose after diagnostic angiography, with concomitant acetylysalicylic acid (160 mg to 500mg loading dose followed by a daily maintenance dose of 75 mg to 100 mg)
Inhibition of the P2Y12 Receptor at 2 Hours After Loading Doses of Ticagrelor and Clopidogrel as Measured by P2Y12 Reaction Units (PRU) From VerifyNow™	98.4 PRU Standard Deviation 95.4	257.5 PRU Standard Deviation 74.5

SECONDARY outcome

Timeframe: 0.5 hours, end of PCI, and 8 hours after the loading dose

Population: PD Analysis Set. Participants in the PD Analysis Set with low (\<150) baseline PRU values were excluded from the analyses.

Participants with low (<150) baseline PRU values were excluded.

Outcome measures

Measure	Ticagrelor n=44 Participants 180 mg loading dose after diagnostic angiography, followed by 90 mg after 12 hours (± 1 hour), with concomitant acetylysalicylic acid (160 mg to 500mg loading dose followed by a daily maintenance dose of 75 mg to 100 mg)	Clopidogrel n=45 Participants 600 mg loading dose after diagnostic angiography, with concomitant acetylysalicylic acid (160 mg to 500mg loading dose followed by a daily maintenance dose of 75 mg to 100 mg)
Inhibition of the P2Y12 Receptor at 0.5 Hours, End of PCI, and 8 Hours After Loading Doses of Ticagrelor and Clopidogrel as Measured by PRU From VerifyNow™ 0.5 hours	277.3 PRU Standard Deviation 73.8	297.7 PRU Standard Deviation 69.2
Inhibition of the P2Y12 Receptor at 0.5 Hours, End of PCI, and 8 Hours After Loading Doses of Ticagrelor and Clopidogrel as Measured by PRU From VerifyNow™ 8 hours	43.8 PRU Standard Deviation 45.7	202.3 PRU Standard Deviation 89.1
Inhibition of the P2Y12 Receptor at 0.5 Hours, End of PCI, and 8 Hours After Loading Doses of Ticagrelor and Clopidogrel as Measured by PRU From VerifyNow™ End of PCI (n=41 for ticagrelor)	264.2 PRU Standard Deviation 92.2	307.8 PRU Standard Deviation 59.5

Adverse Events

Ticagrelor

Serious events: 9 serious events

Other events: 5 other events

Deaths: 0 deaths

Clopidogrel

Serious events: 5 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	Ticagrelor n=51 participants at risk 180 mg loading dose after diagnostic angiography, followed by 90 mg after 12 hours (± 1 hour), with concomitant acetylysalicylic acid (160 mg to 500mg loading dose followed by a daily maintenance dose of 75 mg to 100 mg)	Clopidogrel n=49 participants at risk 600 mg loading dose after diagnostic angiography, with concomitant acetylysalicylic acid (160 mg to 500mg loading dose followed by a daily maintenance dose of 75 mg to 100 mg)
Gastrointestinal disorders Duodenitis	2.0% 1/51 • Number of events 1 • All adverse events (AEs), including serious AEs were monitored from the point of informed consent through the 14 day follow up period. All vascular events were assessed at each visit and could be reported by participants at any time during the study. AEs were solicited at each scheduled visit and could be reported by the participant at any time during the study.	0.00% 0/49 • All adverse events (AEs), including serious AEs were monitored from the point of informed consent through the 14 day follow up period. All vascular events were assessed at each visit and could be reported by participants at any time during the study. AEs were solicited at each scheduled visit and could be reported by the participant at any time during the study.
General disorders Chest pain	3.9% 2/51 • Number of events 2 • All adverse events (AEs), including serious AEs were monitored from the point of informed consent through the 14 day follow up period. All vascular events were assessed at each visit and could be reported by participants at any time during the study. AEs were solicited at each scheduled visit and could be reported by the participant at any time during the study.	2.0% 1/49 • Number of events 1 • All adverse events (AEs), including serious AEs were monitored from the point of informed consent through the 14 day follow up period. All vascular events were assessed at each visit and could be reported by participants at any time during the study. AEs were solicited at each scheduled visit and could be reported by the participant at any time during the study.
Infections and infestations Pneumonia	0.00% 0/51 • All adverse events (AEs), including serious AEs were monitored from the point of informed consent through the 14 day follow up period. All vascular events were assessed at each visit and could be reported by participants at any time during the study. AEs were solicited at each scheduled visit and could be reported by the participant at any time during the study.	2.0% 1/49 • Number of events 1 • All adverse events (AEs), including serious AEs were monitored from the point of informed consent through the 14 day follow up period. All vascular events were assessed at each visit and could be reported by participants at any time during the study. AEs were solicited at each scheduled visit and could be reported by the participant at any time during the study.
Metabolism and nutrition disorders Lactic acidosis	2.0% 1/51 • Number of events 1 • All adverse events (AEs), including serious AEs were monitored from the point of informed consent through the 14 day follow up period. All vascular events were assessed at each visit and could be reported by participants at any time during the study. AEs were solicited at each scheduled visit and could be reported by the participant at any time during the study.	0.00% 0/49 • All adverse events (AEs), including serious AEs were monitored from the point of informed consent through the 14 day follow up period. All vascular events were assessed at each visit and could be reported by participants at any time during the study. AEs were solicited at each scheduled visit and could be reported by the participant at any time during the study.
Nervous system disorders Grand mal convulsion	2.0% 1/51 • Number of events 1 • All adverse events (AEs), including serious AEs were monitored from the point of informed consent through the 14 day follow up period. All vascular events were assessed at each visit and could be reported by participants at any time during the study. AEs were solicited at each scheduled visit and could be reported by the participant at any time during the study.	0.00% 0/49 • All adverse events (AEs), including serious AEs were monitored from the point of informed consent through the 14 day follow up period. All vascular events were assessed at each visit and could be reported by participants at any time during the study. AEs were solicited at each scheduled visit and could be reported by the participant at any time during the study.
Nervous system disorders Partial seizures	2.0% 1/51 • Number of events 1 • All adverse events (AEs), including serious AEs were monitored from the point of informed consent through the 14 day follow up period. All vascular events were assessed at each visit and could be reported by participants at any time during the study. AEs were solicited at each scheduled visit and could be reported by the participant at any time during the study.	0.00% 0/49 • All adverse events (AEs), including serious AEs were monitored from the point of informed consent through the 14 day follow up period. All vascular events were assessed at each visit and could be reported by participants at any time during the study. AEs were solicited at each scheduled visit and could be reported by the participant at any time during the study.
Vascular disorders Hypotension	3.9% 2/51 • Number of events 2 • All adverse events (AEs), including serious AEs were monitored from the point of informed consent through the 14 day follow up period. All vascular events were assessed at each visit and could be reported by participants at any time during the study. AEs were solicited at each scheduled visit and could be reported by the participant at any time during the study.	0.00% 0/49 • All adverse events (AEs), including serious AEs were monitored from the point of informed consent through the 14 day follow up period. All vascular events were assessed at each visit and could be reported by participants at any time during the study. AEs were solicited at each scheduled visit and could be reported by the participant at any time during the study.
Cardiac disorders Atrioventricular block second degree	2.0% 1/51 • Number of events 1 • All adverse events (AEs), including serious AEs were monitored from the point of informed consent through the 14 day follow up period. All vascular events were assessed at each visit and could be reported by participants at any time during the study. AEs were solicited at each scheduled visit and could be reported by the participant at any time during the study.	0.00% 0/49 • All adverse events (AEs), including serious AEs were monitored from the point of informed consent through the 14 day follow up period. All vascular events were assessed at each visit and could be reported by participants at any time during the study. AEs were solicited at each scheduled visit and could be reported by the participant at any time during the study.
Cardiac disorders Bradycardia	2.0% 1/51 • Number of events 1 • All adverse events (AEs), including serious AEs were monitored from the point of informed consent through the 14 day follow up period. All vascular events were assessed at each visit and could be reported by participants at any time during the study. AEs were solicited at each scheduled visit and could be reported by the participant at any time during the study.	0.00% 0/49 • All adverse events (AEs), including serious AEs were monitored from the point of informed consent through the 14 day follow up period. All vascular events were assessed at each visit and could be reported by participants at any time during the study. AEs were solicited at each scheduled visit and could be reported by the participant at any time during the study.
Cardiac disorders Tachycardia	2.0% 1/51 • Number of events 1 • All adverse events (AEs), including serious AEs were monitored from the point of informed consent through the 14 day follow up period. All vascular events were assessed at each visit and could be reported by participants at any time during the study. AEs were solicited at each scheduled visit and could be reported by the participant at any time during the study.	0.00% 0/49 • All adverse events (AEs), including serious AEs were monitored from the point of informed consent through the 14 day follow up period. All vascular events were assessed at each visit and could be reported by participants at any time during the study. AEs were solicited at each scheduled visit and could be reported by the participant at any time during the study.
Cardiac disorders Angina unstable	0.00% 0/51 • All adverse events (AEs), including serious AEs were monitored from the point of informed consent through the 14 day follow up period. All vascular events were assessed at each visit and could be reported by participants at any time during the study. AEs were solicited at each scheduled visit and could be reported by the participant at any time during the study.	6.1% 3/49 • Number of events 4 • All adverse events (AEs), including serious AEs were monitored from the point of informed consent through the 14 day follow up period. All vascular events were assessed at each visit and could be reported by participants at any time during the study. AEs were solicited at each scheduled visit and could be reported by the participant at any time during the study.
Cardiac disorders Coronary artery disease	0.00% 0/51 • All adverse events (AEs), including serious AEs were monitored from the point of informed consent through the 14 day follow up period. All vascular events were assessed at each visit and could be reported by participants at any time during the study. AEs were solicited at each scheduled visit and could be reported by the participant at any time during the study.	2.0% 1/49 • Number of events 1 • All adverse events (AEs), including serious AEs were monitored from the point of informed consent through the 14 day follow up period. All vascular events were assessed at each visit and could be reported by participants at any time during the study. AEs were solicited at each scheduled visit and could be reported by the participant at any time during the study.
Injury, poisoning and procedural complications Vascular pseudoaneurysm	2.0% 1/51 • Number of events 1 • All adverse events (AEs), including serious AEs were monitored from the point of informed consent through the 14 day follow up period. All vascular events were assessed at each visit and could be reported by participants at any time during the study. AEs were solicited at each scheduled visit and could be reported by the participant at any time during the study.	0.00% 0/49 • All adverse events (AEs), including serious AEs were monitored from the point of informed consent through the 14 day follow up period. All vascular events were assessed at each visit and could be reported by participants at any time during the study. AEs were solicited at each scheduled visit and could be reported by the participant at any time during the study.
Injury, poisoning and procedural complications Fall	0.00% 0/51 • All adverse events (AEs), including serious AEs were monitored from the point of informed consent through the 14 day follow up period. All vascular events were assessed at each visit and could be reported by participants at any time during the study. AEs were solicited at each scheduled visit and could be reported by the participant at any time during the study.	2.0% 1/49 • Number of events 1 • All adverse events (AEs), including serious AEs were monitored from the point of informed consent through the 14 day follow up period. All vascular events were assessed at each visit and could be reported by participants at any time during the study. AEs were solicited at each scheduled visit and could be reported by the participant at any time during the study.

Other adverse events

Measure	Ticagrelor n=51 participants at risk 180 mg loading dose after diagnostic angiography, followed by 90 mg after 12 hours (± 1 hour), with concomitant acetylysalicylic acid (160 mg to 500mg loading dose followed by a daily maintenance dose of 75 mg to 100 mg)	Clopidogrel n=49 participants at risk 600 mg loading dose after diagnostic angiography, with concomitant acetylysalicylic acid (160 mg to 500mg loading dose followed by a daily maintenance dose of 75 mg to 100 mg)
General disorders Chest pain	3.9% 2/51 • Number of events 2 • All adverse events (AEs), including serious AEs were monitored from the point of informed consent through the 14 day follow up period. All vascular events were assessed at each visit and could be reported by participants at any time during the study. AEs were solicited at each scheduled visit and could be reported by the participant at any time during the study.	0.00% 0/49 • All adverse events (AEs), including serious AEs were monitored from the point of informed consent through the 14 day follow up period. All vascular events were assessed at each visit and could be reported by participants at any time during the study. AEs were solicited at each scheduled visit and could be reported by the participant at any time during the study.
Respiratory, thoracic and mediastinal disorders Dyspnoea	3.9% 2/51 • Number of events 2 • All adverse events (AEs), including serious AEs were monitored from the point of informed consent through the 14 day follow up period. All vascular events were assessed at each visit and could be reported by participants at any time during the study. AEs were solicited at each scheduled visit and could be reported by the participant at any time during the study.	2.0% 1/49 • Number of events 1 • All adverse events (AEs), including serious AEs were monitored from the point of informed consent through the 14 day follow up period. All vascular events were assessed at each visit and could be reported by participants at any time during the study. AEs were solicited at each scheduled visit and could be reported by the participant at any time during the study.
Vascular disorders Haematoma	3.9% 2/51 • Number of events 2 • All adverse events (AEs), including serious AEs were monitored from the point of informed consent through the 14 day follow up period. All vascular events were assessed at each visit and could be reported by participants at any time during the study. AEs were solicited at each scheduled visit and could be reported by the participant at any time during the study.	0.00% 0/49 • All adverse events (AEs), including serious AEs were monitored from the point of informed consent through the 14 day follow up period. All vascular events were assessed at each visit and could be reported by participants at any time during the study. AEs were solicited at each scheduled visit and could be reported by the participant at any time during the study.

Additional Information

Tomas LG Andersson, MD, PhD

AstraZeneca

Phone: 1-800-236-9393

Email: ClinicalTrialTransparency@astrazeneca.com

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