Trial Outcomes & Findings for Trial of Clopidogrel After Surgery for Coronary Artery Disease (CASCADE Trial) (NCT NCT00228423)

NCT ID: NCT00228423

Last Updated: 2021-04-27

Results Overview

IVUS imaging 12 months post-CABG, and the average intimal area in the proximal 40 mm of one vein graft per patient will be assessed

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 113 participants
• Primary outcome timeframe: One year following surgery
• Results posted on: 2021-04-27

Participant Flow

Participant milestones

Measure	75mg Clopidogrel 75mg clopidogrel. 162mg ASA is also given, but is a standard-of-care post operative to cardiac surgery. Clopidogrel 75 mg daily: Daily dose of 75 mg Clopidogrel	Placebo Water pill. 162mg ASA is also given, but is a standard-of-care post operative to cardiac surgery. water pill daily: Daily dose of water pill (placebo)
Overall Study STARTED	56	57
Overall Study COMPLETED	46	45
Overall Study NOT COMPLETED	10	12

Reasons for withdrawal

Measure	75mg Clopidogrel 75mg clopidogrel. 162mg ASA is also given, but is a standard-of-care post operative to cardiac surgery. Clopidogrel 75 mg daily: Daily dose of 75 mg Clopidogrel	Placebo Water pill. 162mg ASA is also given, but is a standard-of-care post operative to cardiac surgery. water pill daily: Daily dose of water pill (placebo)
Overall Study Adverse Event	2	5
Overall Study Withdrawal by Subject	7	3
Overall Study Protocol Violation	1	3
Overall Study Physician Decision	0	1

Baseline Characteristics

Trial of Clopidogrel After Surgery for Coronary Artery Disease (CASCADE Trial)

Baseline characteristics by cohort

Measure	75mg Clopidogrel n=56 Participants 75mg clopidogrel. 162mg ASA is also given, but is a standard-of-care post operative to cardiac surgery. Clopidogrel 75 mg daily: Daily dose of 75 mg Clopidogrel	Placebo n=57 Participants Water pill. 162mg ASA is also given, but is a standard-of-care post operative to cardiac surgery. water pill daily: Daily dose of water pill (placebo)	Total n=113 Participants Total of all reporting groups
Age, Continuous	64.9 years STANDARD_DEVIATION 7.5 • n=5 Participants	68.1 years STANDARD_DEVIATION 7.4 • n=7 Participants	66.0 years STANDARD_DEVIATION 7.4 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	7 Participants n=7 Participants	12 Participants n=5 Participants
Sex: Female, Male Male	51 Participants n=5 Participants	50 Participants n=7 Participants	101 Participants n=5 Participants

PRIMARY outcome

Timeframe: One year following surgery

IVUS imaging 12 months post-CABG, and the average intimal area in the proximal 40 mm of one vein graft per patient will be assessed

Outcome measures

Measure	75mg Clopidogrel n=46 Participants 75mg clopidogrel. 162mg ASA is also given, but is a standard-of-care post operative to cardiac surgery. Clopidogrel 75 mg daily: Daily dose of 75 mg Clopidogrel	Placebo n=44 Participants Water pill. 162mg ASA is also given, but is a standard-of-care post operative to cardiac surgery. water pill daily: Daily dose of water pill (placebo)
Vein Graft Intimal Area	4.1 mm Standard Deviation 2.0	4.5 mm Standard Deviation 2.1

SECONDARY outcome

Timeframe: One year following surgery

Postoperative angiogram 12 months post-CABG

Outcome measures

Measure	75mg Clopidogrel n=46 Participants 75mg clopidogrel. 162mg ASA is also given, but is a standard-of-care post operative to cardiac surgery. Clopidogrel 75 mg daily: Daily dose of 75 mg Clopidogrel	Placebo n=44 Participants Water pill. 162mg ASA is also given, but is a standard-of-care post operative to cardiac surgery. water pill daily: Daily dose of water pill (placebo)
Vein Graft Angiographic Patency	94.3 percentage	93.2 percentage

SECONDARY outcome

Timeframe: 1 year

Outcome measures

Measure	75mg Clopidogrel n=56 Participants 75mg clopidogrel. 162mg ASA is also given, but is a standard-of-care post operative to cardiac surgery. Clopidogrel 75 mg daily: Daily dose of 75 mg Clopidogrel	Placebo n=57 Participants Water pill. 162mg ASA is also given, but is a standard-of-care post operative to cardiac surgery. water pill daily: Daily dose of water pill (placebo)
Incidence of Major Adverse Coronary Events Within One Year Following Surgery	4 Participants	5 Participants

SECONDARY outcome

Timeframe: 1 year

Outcome measures

Measure	75mg Clopidogrel n=56 Participants 75mg clopidogrel. 162mg ASA is also given, but is a standard-of-care post operative to cardiac surgery. Clopidogrel 75 mg daily: Daily dose of 75 mg Clopidogrel	Placebo n=57 Participants Water pill. 162mg ASA is also given, but is a standard-of-care post operative to cardiac surgery. water pill daily: Daily dose of water pill (placebo)
Incidence of Major Bleeding Events Within One Year Following Surgery	1 Participants	0 Participants

Adverse Events

75mg Clopidogrel

Serious events: 4 serious events

Other events: 3 other events

Deaths: 0 deaths

Placebo

Serious events: 5 serious events

Other events: 3 other events

Deaths: 1 deaths

Serious adverse events

Measure	75mg Clopidogrel n=56 participants at risk 75mg clopidogrel. 162mg ASA is also given, but is a standard-of-care post operative to cardiac surgery. Clopidogrel 75 mg daily: Daily dose of 75 mg Clopidogrel	Placebo n=57 participants at risk Water pill. 162mg ASA is also given, but is a standard-of-care post operative to cardiac surgery. water pill daily: Daily dose of water pill (placebo)
Cardiac disorders Myocardial infarction	7.1% 4/56 • Number of events 4 • 1 year	0.00% 0/57 • 1 year
Cardiac disorders Cerebrovascular accident	0.00% 0/56 • 1 year	3.5% 2/57 • Number of events 2 • 1 year
Cardiac disorders Hospitalization for Coronary Ischemia	0.00% 0/56 • 1 year	5.3% 3/57 • Number of events 3 • 1 year

Other adverse events

Measure	75mg Clopidogrel n=56 participants at risk 75mg clopidogrel. 162mg ASA is also given, but is a standard-of-care post operative to cardiac surgery. Clopidogrel 75 mg daily: Daily dose of 75 mg Clopidogrel	Placebo n=57 participants at risk Water pill. 162mg ASA is also given, but is a standard-of-care post operative to cardiac surgery. water pill daily: Daily dose of water pill (placebo)
General disorders Minor bleeding	5.4% 3/56 • Number of events 3 • 1 year	5.3% 3/57 • Number of events 3 • 1 year

Additional Information

Dr. Marc Ruel

University Of Ottawa Heart Institute

Email: mruel@ottawaheart.ca

Results disclosure agreements

• Principal investigator is a sponsor employee The first publication will be a joint effort between all contributing parties. At least 30 days before submission for publication, the partnership will be provided the proposed publication and will be given 30 days to respond with approval or requests for holds. All contributing parties must be acknowledged in all publications.
• Publication restrictions are in place

Restriction type: OTHER