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

Sponsored by:	LifeBridge Health
Information provided by:	LifeBridge Health
ClinicalTrials.gov Identifier:	NCT00857155

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:	Diagnostic, Non-Randomized, Open Label, Parallel Assignment, Safety Study

Resource links provided by NLM:

MedlinePlus related topics: Coronary Artery Bypass Surgery Coronary Artery Disease Surgery

Drug Information available for: Clopidogrel Clopidogrel Bisulfate

U.S. FDA Resources

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
Aspirin only: No Intervention 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

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

Responsible Party:	LifeBridge Health ( Paul A. Gurbel MD )
Study ID Numbers:	IRB# 1464
Study First Received:	March 4, 2009
Last Updated:	March 5, 2009
ClinicalTrials.gov Identifier:	NCT00857155 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by LifeBridge Health:

Coronary Artery Disease
CABG
Clopidogrel
Aspirin
Point of Care devices

Study placed in the following topic categories:

Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Aspirin
Clopidogrel
Myocardial Ischemia

Vascular Diseases
Platelet Aggregation Inhibitors
Arteriosclerosis
Ischemia
Hemorrhage
Coronary Artery Disease

Additional relevant MeSH terms:

Arterial Occlusive Diseases
Heart Diseases
Myocardial Ischemia
Hematologic Agents
Vascular Diseases
Arteriosclerosis
Pharmacologic Actions

Coronary Disease
Clopidogrel
Therapeutic Uses
Cardiovascular Diseases
Platelet Aggregation Inhibitors
Coronary Artery Disease

ClinicalTrials.gov processed this record on September 10, 2009