Trial Outcomes & Findings for Aspirin and Plavix Following Coronary Artery Bypass Grafting (NCT NCT01158703)

NCT ID: NCT01158703

Last Updated: 2015-05-19

Results Overview

Incidence of more than 50% stenosis in graft with combination therapy with aspirin and clopidogrel vs. aspirin and placebo

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 20 participants
• Primary outcome timeframe: 52 weeks
• Results posted on: 2015-05-19

Participant Flow

Participant milestones

Measure	Clopidogrel aspirin and clopidogrel clopidogrel: clopidogrel 75mg daily and aspirin 81mg by mouth daily for 12 months	Sugar Pill aspirin and placebo sugar pill: sugar pill and aspirin 81mg by mouth daily for 12 months
Overall Study STARTED	12	8
Overall Study COMPLETED	12	8
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Aspirin and Plavix Following Coronary Artery Bypass Grafting

Baseline characteristics by cohort

Measure	Clopidogrel n=12 Participants aspirin and clopidogrel clopidogrel: clopidogrel 75mg daily and aspirin 81mg by mouth daily for 12 months	Sugar Pill n=8 Participants aspirin and placebo sugar pill: sugar pill and aspirin 81mg by mouth daily for 12 months	Total n=20 Participants Total of all reporting groups
Age, Continuous	67.4 years STANDARD_DEVIATION 9.7 • n=5 Participants	64.8 years STANDARD_DEVIATION 10.2 • n=7 Participants	66.4 years STANDARD_DEVIATION 9.9 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	7 Participants n=7 Participants	18 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants	8 participants n=7 Participants	20 participants n=5 Participants
Systolic Blood Pressure	117.8 mmHg STANDARD_DEVIATION 10.7 • n=5 Participants	115.4 mmHg STANDARD_DEVIATION 12.34 • n=7 Participants	116.8 mmHg STANDARD_DEVIATION 11.6 • n=5 Participants
Diastolic Blood Pressure	69.5 mmHg STANDARD_DEVIATION 9.1 • n=5 Participants	65.1 mmHg STANDARD_DEVIATION 7.3 • n=7 Participants	67.8 mmHg STANDARD_DEVIATION 8.5 • n=5 Participants

PRIMARY outcome

Timeframe: 52 weeks

Population: Incidence of more than 50% stenosis in graft with combination therapy with aspirin and clopidogrel vs. aspirin and placebo

Incidence of more than 50% stenosis in graft with combination therapy with aspirin and clopidogrel vs. aspirin and placebo

Outcome measures

Measure	Clopidogrel n=36 grafts aspirin and clopidogrel clopidogrel: clopidogrel 75mg daily and aspirin 81mg by mouth daily for 12 months	Sugar Pill n=27 grafts aspirin and placebo sugar pill: sugar pill and aspirin 81mg by mouth daily for 12 months
Incidence of More Than 50% Stenosis in Graft With Combination Therapy With Aspirin and Clopidogrel vs. Aspirin Alone	10 occluded grafts	9 occluded grafts

SECONDARY outcome

Timeframe: 52 weeks

Outcome measures

Measure	Clopidogrel n=12 Participants aspirin and clopidogrel clopidogrel: clopidogrel 75mg daily and aspirin 81mg by mouth daily for 12 months	Sugar Pill n=8 Participants aspirin and placebo sugar pill: sugar pill and aspirin 81mg by mouth daily for 12 months
Incidence of Bleeding Between the Two Treatment Arms	0 BLEEDING EVENTS	0 BLEEDING EVENTS

SECONDARY outcome

Timeframe: 52 weeks

Population: above is the total number of all events reported

Number of major adverse cardiovascular events(angina, any thrombotic events, and myocardial infarction) with combination therapy with aspirin and clopidogrel vs. aspirin alone

Outcome measures

Measure	Clopidogrel n=10 All events aspirin and clopidogrel clopidogrel: clopidogrel 75mg daily and aspirin 81mg by mouth daily for 12 months	Sugar Pill n=6 All events aspirin and placebo sugar pill: sugar pill and aspirin 81mg by mouth daily for 12 months
Number of Major Adverse Cardiovascular Events With Combination Therapy	10 MACE Events over 52Wks	6 MACE Events over 52Wks

SECONDARY outcome

Timeframe: 52 weeks

Population: above is the total number of participants

Number of angina events with combination therapy with aspirin and clopidogrel vs. aspirin alone

Outcome measures

Measure	Clopidogrel n=12 Participants aspirin and clopidogrel clopidogrel: clopidogrel 75mg daily and aspirin 81mg by mouth daily for 12 months	Sugar Pill n=8 Participants aspirin and placebo sugar pill: sugar pill and aspirin 81mg by mouth daily for 12 months
Number of Angina Events	7 Angina Events over 52Wks	5 Angina Events over 52Wks

SECONDARY outcome

Timeframe: 52 weeks

Population: above is the total number of participants

Number of myocardial infarction events with combination therapy with aspirin and clopidogrel vs. aspirin alone

Outcome measures

Measure	Clopidogrel n=12 Participants aspirin and clopidogrel clopidogrel: clopidogrel 75mg daily and aspirin 81mg by mouth daily for 12 months	Sugar Pill n=8 Participants aspirin and placebo sugar pill: sugar pill and aspirin 81mg by mouth daily for 12 months
Number of Myocardial Infarction Events	2 MI Events over 52Wks	1 MI Events over 52Wks

SECONDARY outcome

Timeframe: 52 weeks

Population: above is the total number of participants

Number of thrombotic events with combination therapy with aspirin and clopidogrel vs. aspirin alone

Outcome measures

Measure	Clopidogrel n=12 Participants aspirin and clopidogrel clopidogrel: clopidogrel 75mg daily and aspirin 81mg by mouth daily for 12 months	Sugar Pill n=8 Participants aspirin and placebo sugar pill: sugar pill and aspirin 81mg by mouth daily for 12 months
Number of Thrombotic Events	1 thrombotic Events over 52Wks	0 thrombotic Events over 52Wks

Adverse Events

Clopidogrel

Serious events: 10 serious events

Other events: 0 other events

Deaths: 0 deaths

Sugar Pill

Serious events: 6 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Clopidogrel n=12 participants at risk aspirin and clopidogrel clopidogrel: clopidogrel 75mg daily and aspirin 81mg by mouth daily for 12 months	Sugar Pill n=12 participants at risk；n=8 participants at risk aspirin and placebo sugar pill: sugar pill and aspirin 81mg by mouth daily for 12 months
Cardiac disorders Number of Angina Events	58.3% 7/12 • Number of events 7 • 52 weeks 52 weeks events of bleeding ( TIMI Major and Minor)	62.5% 5/8 • Number of events 5 • 52 weeks 52 weeks events of bleeding ( TIMI Major and Minor)
Cardiac disorders Number of Myocardial Infarction Events	16.7% 2/12 • Number of events 2 • 52 weeks 52 weeks events of bleeding ( TIMI Major and Minor)	12.5% 1/8 • Number of events 1 • 52 weeks 52 weeks events of bleeding ( TIMI Major and Minor)
Vascular disorders Number of Thrombotic Events	8.3% 1/12 • Number of events 1 • 52 weeks 52 weeks events of bleeding ( TIMI Major and Minor)	0.00% 0/8 • 52 weeks 52 weeks events of bleeding ( TIMI Major and Minor)

Other adverse events

Adverse event data not reported

Additional Information

AHMAD M. SLIM, MD, LTC, MC

BROOKE ARMY MEDICAL CENTER

Phone: 210-916-4717

Email: AHMAD.SLIM@US.ARMY.MIL

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place