Angiomax in Patients With HIT/HITTS Type II Undergoing Off-Pump Coronary Artery Bypass Grafting (CABG) (CHOOSE)

Phase 3

Completed

• Conditions: Thrombocytopenia; Cardiac Disease; Thrombosis; Coronary Artery Bypass Surgery

• Registration Number: NCT00073580
• Lead Sponsor: The Medicines Company

Brief Summary

The purpose of this study is to examine the safety and efficacy of Angiomax as an anticoagulation in patients with heparin-induced thrombocytopenia (HIT)/heparin-induced thrombocytopenia with thrombosis syndrome (HITTS) undergoing off-pump coronary artery bypass (OPCAB) surgery.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-10
• Study First Submitted: 2003-11-26
• Study First Submitted QC: 2003-11-26
• Study First Posted: 2003-11-27
• Primary Completion: 2005-09
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-29
• Last Update Posted: 2018-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

Not provided

Exclusion Criteria

• Confirmed pregnancy, by urine or serum pregnancy test (if woman of child-bearing potential).
• Cerebrovascular accident within 6 months, or any cerebrovascular accident with a residual neurological deficit.
• Intracranial neoplasm, arteriovenous malformation, or aneurysm.
• Dependency on renal dialysis or creatinine clearance <30mL/min.
• Ongoing treatment with warfarin (or other oral anticoagulant) at the time of enrollment.

Patients previously treated with warfarin may be enrolled if warfarin therapy can be safely discontinued and baseline INR is < 1.3 times control in the absence of heparin therapy.

• Known allergy to Angiomax or hirudin derived drugs, or known sensitivity to any component of the product.
• Patients receiving clopidogrel (Plavix®) within the previous 5 days may be enrolled if in the opinion of the Investigator the benefits of surgery outweigh the risk associated with recent clopidogrel administration.
• Patients receiving a glycoprotein IIb/IIIa inhibitor within the previous 48 hours if abciximab (ReoPro®) or 12 hours if eptifibatide (Integrilin®) or tirofiban (Aggrastat®), may be enrolled if in the opinion of the investigator the benefits of surgery outweigh the risk associated with not waiting the 48 or 12 hour time period prior to enrollment.
• Patients receiving lepirudin (Refludan®) or argatroban within the previous 24 hours prior to enrollment. Patients currently receiving lepirudin or argatroban can be enrolled if they are switched to Angiomax at least 24 hours prior to the contemplated OPCAB.
• Patients receiving low molecular weight heparin (LMWH) or thrombolytics within the previous 12 hours may be enrolled if in the opinion of the Investigator the benefits of surgery outweigh the risk associated with not waiting the 12 hour time period.
• Participation in other clinical research studies involving the evaluation of other investigational drugs or devices within 30 days of randomization.
• Refusal to undergo blood transfusion should it become necessary.
• Any other disease or condition, which, in the judgment of the investigator would place a patient at undue risk by being enrolled in the trial or inability to comply with study requirements.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Primary Endpoint	7 days	: In-hospital acute procedural success, defined as the absence of death, Q wave myocardial infarction (MI), repeat coronary revascularization, and stroke (hemorrhagic or ischemic) at hospital discharge or Day 7 after surgery ('Day 7/discharge'), whichever occurs first.

Trial Locations

Locations (1)

The Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States