Recruiting

Clopidogrel

Sponsor:

LifeBridge Health

Code:

NCT00857155

Conditions

Coronary Artery Disease

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Clopidogrel withdraw prior to CABG

Study Details

Brief summary:

Purpose: In patients with coronary artery disease, aspirin and Plavix are used increasingly to prevent the formation of blood clots in the coronary arteries. These drugs exert their beneficial effects by irreversibly blocking platelets, the compounds found in blood responsible for clotting after an injury or during a heart attack. However, these effects also place patients at increased risk for bleeding after coronary artery bypass surgery. Therefore, it is currently recommended to withhold Plavix therapy for 5 days before undergoing surgery in order to reduce the incidence of bleeding. However, it has been repeatedly shown that Plavix exerts variable effects on different patients, which may be partially explained by poor absorption, drug-drug interaction, and by variations in deoxyribonucleic acid (DNA) which constitutes your genes. In addition, the time required for platelets to regain function after Plavix treatment has been shown to vary between patients. Therefore, by measuring platelet function, it may be possible to determine the optimal amount of time required to withhold Plavix before undergoing bypass surgery, which may improve rates of bleeding following the procedure. The purpose of this study is to classify patients into groups based on platelet function in order to define the ideal time period for delaying surgery. By analyzing the amount of time required for platelet recovery, it is expected that surgery-related bleeding will decrease without increasing the risk of blood clot formation.

Eligibility: Approximately 200 patients requiring CABG will be enrolled at Sinai Hospital, which is the only site where this study is being conducted.

To be eligible you must:

  • Be able to provide written informed consent.
  • Be between the ages of 18-85 and require CABG.
  • Currently be on aspirin therapy (81-325mg).

Conditions

Coronary Artery Disease

Study ID

NCT00857155

Start date

Jan, 2009

Status verified date

Mar, 2009

Completion date

Feb, 2011

Anticipated

Primary completion date

Jan, 2011

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients must provide written informed consent.
  • Patients must currently be on aspirin therapy (81-325 mg).
  • Male or female patients between the ages of 18-85 requiring CABG.

Exclusion Criteria:

  • Patients undergoing emergent surgery following failed percutaneous coronary revascularization.
  • Patients with a history of previous cardiac surgery and patients needing concomitant valvular surgery.
  • Pre-operative exposure to either coumadin or platelet GPIIb/IIIa inhibitors.
  • Patients with a history of bleeding diathesis.
  • Patients with an activated partial thrombin time >1.5 normal.
  • Patients with platelet count <120,000/mm3.
  • Patients with hematocrit <30%.
  • Patients with creatinine clearance <30mL/min.
  • Patients with known active hepatic disease.
  • Patients with any other condition that, in the opinion of the investigator, may either put the patient at risk or influence the result of the study (e.g. malignancy, limiting life expectancy, noncompliance).

Study Design

Enrollment

200 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

no intervention: Aspirin only

Continue aspirin until surgery

other: Clopidogrel and Aspirin

Interventions

Clopidogrel withdraw prior to CABG

Patients on clopidogrel are stratified into time-based platelet function recovery groups as determined by point of care methods and based on these groups clopidogrel is withdrawn at a pre-specified timepoint before surgery.

Primary outcome measure

  • The primary endpoint is chest tube drainage. [ Time Frame: During the index hospitalization ]

Central Contacts and Locations

Central contacts

Kevin P Bliden, BS

4106014795kbliden@lifebridgehealth.org

Paul P Gurbel, MD

4106019600pgurbel@lifebridgehealth.org

Locations

Sinai Hospital

Recruiting

Baltimore, Maryland, United States, 21215

More Information

Sponsor

LifeBridge Health

Last update posted

Mar 6, 2009

Last verified

Mar, 2009

Keywords

  • Coronary Artery Disease
  • CABG
  • Clopidogrel
  • Aspirin
  • Point of Care devices

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by LifeBridge Health on 2009-03-06.