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

Coronary Artery Disease Clinical Trial

— TARGET-CABG  

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00857155
• Other study ID #: IRB# 1464
• Status: Recruiting
• Phase: N/A
• First received: March 4, 2009
• Last updated: March 5, 2009
• Start date: January 2009
• Est. completion date: February 2011

Study information

• Verified date: March 2009
• Source: LifeBridge Health
• Contact: Kevin P Bliden, BS
• Phone: 4106014795
• Email: kbliden[@]lifebridgehealth.org
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: February 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

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.

Locations

Country	Name	City	State
United States	Sinai Hospital	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
LifeBridge Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary endpoint is chest tube drainage.		During the index hospitalization	Yes
Secondary	The secondary endpoint is transfusion requirements.		Index hospitalization	Yes