NCT00857155: TARGET-CABG

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

Status unknown NA Last updated 5 March 2009

What this trial tests

NA trial testing Clopidogrel withdraw prior to CABG in Coronary Artery Disease in 200 participants. Status unknown.

Timeline

1 January 2009

Primary endpoint
1 January 2011

1 February 2011

Quick facts

Lead sponsor	LifeBridge Health
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	diagnostic
Enrollment	200
Start date	1 January 2009
Primary completion	1 January 2011
Estimated completion	1 February 2011
Sites	1 location across United States

Drugs / interventions tested

• Clopidogrel withdraw prior to CABG

Conditions studied

• Coronary Artery Disease — all drugs for Coronary Artery Disease →

Sponsor

LifeBridge Health — full company profile →

Who can join

Adults 18 to 85, any sex, with Coronary Artery Disease. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• The primary endpoint is chest tube drainage.
  Time frame: During the index hospitalization

Sponsor's own description

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).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Platelet function measurement-based strategy to reduce bleeding and waiting time in clopidogrel-treated patients undergoing coronary artery bypass graft surgery: the timing based on platelet function strategy to reduce clopidogrel-associated bleeding related to CABG (TARGET-CABG)
   Mahla E, Suarez TA, Bliden KP, Rehak P, et al · · 2012 · cited 175× · PMID 22396581 · DOI 10.1161/circinterventions.111.967208