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

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ClinicalTrials.gov Identifier: NCT00228423
Recruitment Status : Completed
First Posted : September 28, 2005
Results First Posted : April 27, 2021
Last Update Posted : April 27, 2021
Sponsor:
Collaborators:
Sanofi
Bristol-Myers Squibb
Information provided by (Responsible Party):
Ottawa Heart Institute Research Corporation

Study Description
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Brief Summary:
The purpose of this study is to determine whether the combination of clopidogrel with aspirin prevents the development of blockages (atherosclerosis) in vein grafts one year after coronary artery bypass surgery (CABG) compared to aspirin alone.

Condition or disease Intervention/treatment Phase
Atherosclerosis Drug: Clopidogrel 75 mg daily Drug: water pill daily Phase 2

Detailed Description:

Saphenous vein graft disease remains a major limitation of coronary artery bypass graft surgery (CABG). The process of saphenous vein intimal hyperplasia is mediated by platelet aggregation and begins just days after surgical revascularization. Subsequently, areas of intimal hyperplasia in turn develop graft atherosclerotic disease and its sequelae. Clopidogrel improves outcomes in patients with atherosclerotic disease, and is effective at reducing intimal hyperplasia in animal models of thrombosis. Therefore, the goal of this study will be to evaluate the efficacy of clopidogrel and aspirin therapy versus aspirin alone in the prevention of saphenous vein graft intimal hyperplasia following one year after CABG.

Patients undergoing multi-vessel CABG and in whom at least two saphenous vein grafts will be used are eligible for the study. Patients will be randomized to receive daily clopidogrel 75 mg or placebo, in addition to daily aspirin 162 mg, for the duration of one year starting as soon as postoperative bleeding has been ruled out on the day of surgery. At the end of one year, all patients will undergo coronary angiography and intravascular ultrasound assessment of one saphenous vein graft as selected by randomization. The study will be powered to test the hypothesis that clopidogrel and aspirin will reduce vein graft intimal hyperplasia by 20% compared to aspirin alone at one year following bypass surgery.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 113 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Clopidogrel After Surgery for Coronary Artery Disease (CASCADE Trial): Does Clopidogrel Prevent Saphenous Vein Graft Disease After Coronary Bypass?
Study Start Date : May 2006
Actual Primary Completion Date : June 2009
Actual Study Completion Date : July 2009

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 75mg Clopidogrel
75mg clopidogrel. 162mg ASA is also given, but is a standard-of-care post operative to cardiac surgery.
 Drug: Clopidogrel 75 mg daily
Daily dose of 75 mg Clopidogrel
Placebo Comparator: Placebo
Water pill. 162mg ASA is also given, but is a standard-of-care post operative to cardiac surgery.
 Drug: water pill daily
Daily dose of water pill (placebo)


Outcome Measures
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Primary Outcome Measures :
  1. Vein Graft Intimal Area [ Time Frame: 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


Secondary Outcome Measures :
  1. Vein Graft Angiographic Patency [ Time Frame: One year following surgery ]
    Postoperative angiogram 12 months post-CABG

  2. Incidence of Major Adverse Coronary Events Within One Year Following Surgery [ Time Frame: 1 year ]
  3. Incidence of Major Bleeding Events Within One Year Following Surgery [ Time Frame: 1 year ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients undergoing primary multi-vessel CABG with at least two saphenous vein grafts, with or without the use of cardiopulmonary bypass.

Exclusion Criteria:

  • Emergency surgery
  • Valve surgery
  • Redo CABG
  • Left ventricle ejection fraction < 25%
  • Serum creatinine > 130 µmol/L
  • Preoperative use of clopidogrel (with the exception of the current admission)
  • Preoperative use of warfarin; allergy to aspirin or clopidogrel.
  • History of cerebrovascular accident
  • History of severe liver disease
  • Morbid obesity
  • Current malignancy
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00228423


Locations
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Canada, Ontario
University of Ottawa Heart Institute
Ottawa, Ontario, Canada, K1Y 4W7
Sponsors and Collaborators
Ottawa Heart Institute Research Corporation
Sanofi
Bristol-Myers Squibb
Investigators
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Principal Investigator: Marc Ruel, MD, MPH Ottawa Heart Institute Research Corporation
Study Director: Alexander Kulik, MD Ottawa Heart Institute Research Corporation
Study Director: Michel Le May, MD Ottawa Heart Institute Research Corporation
Study Director: George A Wells, PhD Ottawa Heart Institute Research Corporation
Study Director: Thierry G Mesana, MD, PhD Ottawa Heart Institute Research Corporation
More Information
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Additional Information:

Publications of Results:

Other Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Ottawa Heart Institute Research Corporation
ClinicalTrials.gov Identifier: NCT00228423    
Other Study ID Numbers: UOHI 2006-111
First Posted: September 28, 2005    Key Record Dates
Results First Posted: April 27, 2021
Last Update Posted: April 27, 2021
Last Verified: March 2021
Keywords provided by Ottawa Heart Institute Research Corporation:
Saphenous vein
Intimal hyperplasia
Coronary artery bypass graft surgery
 Antiplatelet therapy
Clopidogrel
Saphenous vein graft disease
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Atherosclerosis
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
 Clopidogrel
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs