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

This study has been completed.
Sponsor:
Collaborators:
Sanofi
Bristol-Myers Squibb
Information provided by:
Ottawa Heart Institute Research Corporation
ClinicalTrials.gov Identifier:
NCT00228423
First received: September 26, 2005
Last updated: June 25, 2010
Last verified: June 2010
  Purpose

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 Intervention Phase
Atherosclerosis
Drug: Clopidogrel 75 mg daily
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, 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?

Resource links provided by NLM:


Further study details as provided by Ottawa Heart Institute Research Corporation:

Primary Outcome Measures:
  • Vein graft intimal area, one year following surgery [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Vein graft angiographic patency, one year following surgery [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Incidence of major adverse coronary events within one year following surgery [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Incidence of major bleeding events within one year following surgery [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 92
Study Start Date: May 2006
Study Completion Date: July 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Clopidogrel 75 mg daily
    Daily dose of 75 mg Clopidogrel and 162 mg aspirin or Placebo and 162 mg aspirin during one year
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00228423

Locations
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
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

Additional Information:
Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Marc Ruel, MD, University of Ottawa Heart Institute
ClinicalTrials.gov Identifier: NCT00228423     History of Changes
Other Study ID Numbers: UOHI 2006-111
Study First Received: September 26, 2005
Last Updated: June 25, 2010
Health Authority: Canada: Health Canada

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:
Arteriosclerosis
Atherosclerosis
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Cardiovascular Diseases
Heart Diseases
Vascular Diseases
Clopidogrel
Ticlopidine
Cardiovascular Agents
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Purinergic Agents
Purinergic Antagonists
Purinergic P2 Receptor Antagonists
Purinergic P2Y Receptor Antagonists
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014