Time Based Strategy to Reduce Clopidogrel Associated Bleeding Related to Coronary Artery Bypass Graft (CABG) (TARGET-CABG)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by LifeBridge Health.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
LifeBridge Health
ClinicalTrials.gov Identifier:
NCT00857155
First received: March 4, 2009
Last updated: March 5, 2009
Last verified: March 2009
  Purpose

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).

Condition Intervention
Coronary Artery Disease
Other: Clopidogrel withdraw prior to CABG

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic

Resource links provided by NLM:


Further study details as provided by LifeBridge Health:

Primary Outcome Measures:
  • The primary endpoint is chest tube drainage. [ Time Frame: During the index hospitalization ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The secondary endpoint is transfusion requirements. [ Time Frame: Index hospitalization ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 200
Study Start Date: January 2009
Estimated Study Completion Date: February 2011
Estimated Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Aspirin only
Continue aspirin until surgery
Clopidogrel and Aspirin Other: 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.

Detailed Description:

Primary objective:

We hypothesize that stratifying patients on clopidogrel into time-based platelet function recovery groups as determined by pre-operative clopidogrel response measured by point of care methods will result in similar rates of bleeding as compared to those of clopidogrel naïve patients undergoing elective CABG.

Study design:

This will be a single center, prospective study analyzing clopidogrel naïve patients and patients on clopidogrel with background aspirin therapy requiring CABG.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  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: NCT00857155

Contacts
Contact: Kevin P Bliden, BS 4106014795 kbliden@lifebridgehealth.org
Contact: Paul P Gurbel, MD 4106019600 pgurbel@lifebridgehealth.org

Locations
United States, Maryland
Sinai Hospital Recruiting
Baltimore, Maryland, United States, 21215
Contact: Kevin P Bliden         
Sponsors and Collaborators
LifeBridge Health
  More Information

No publications provided by LifeBridge Health

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Paul A. Gurbel MD, LifeBridge Health
ClinicalTrials.gov Identifier: NCT00857155     History of Changes
Other Study ID Numbers: IRB# 1464
Study First Received: March 4, 2009
Last Updated: March 5, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by LifeBridge Health:
Coronary Artery Disease
CABG
Clopidogrel
Aspirin
Point of Care devices

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Aspirin
Ticlopidine
Clopidogrel
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics

ClinicalTrials.gov processed this record on July 23, 2014