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

NCT00073580 | Completed Phase 3

• 2 other identifiers: TMC-BIV-02-02CHOOSE
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Thrombocytopenia; Thrombosis; Cardiac Disease; Coronary Artery Bypass Surgery

Keywords

HIT; HITTS; Heparin-antibodies; Coronary artery bypass surgery; CABG; Heparin-induced thrombocytopenia; Heparin-induced thrombocytopenia and thrombosis syndrome

Outcome Measures

Primary Outcomes (1)

• Primary Endpoint

  : 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.

  7 days

Interventions

Angiomax (bivalirudin) anticoagulant DRUG

): 250 mg vial administered as 0.75 mg/kg intravenous (IV) bolus and 1.75 mg/kg/h IV infusion for the duration of the procedure with the option to increase or decrease the infusion rate in 0.25 mg/kg/h increments or to administer additional 0.1-0.5 mg/kg boluses to maintain an activated clotting time (ACT+) \>300 seconds. A low-dose infusion could be administered in the preoperative phase (up to 48 hours before the procedure) and in the postoperative phase (up to 14 days after the procedure) as clinically indicated for management of HIT/TS. An initial dose of 0.1 mg/kg IV bolus followed by an IV infusion of 0.2 mg/kg/h titrated to a desired activated partial thromboplastin time (aPTT), eg, 1.5-2.5 times baseline aPTT, was recommended.

Also known as: bivalirudin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be at least 18 years of age.
• Be accepted for OPCAB graft surgery (repeat CABG eligible)
• New diagnosis or history of objectively documented HIT/HITTS Type II, defined as:
• Positive heparin-induced platelet aggregation (HIPA) or other functional assay for HIT or immunoassay for HIT antibodies (ELISA), AND/OR
• HIT: Thrombocytopenia associated with heparin therapy, where the platelet count has decreased by 50%, OR
• HITTS: Thrombocytopenia (as defined in B above) PLUS any arterial or venous thrombosis (Deep-vein thrombosis, pulmonary embolism, mesenteric venouse or arterial thrombosis, acute myocardial infarction, left ventricular thrombus, ischemic stroke, or occlusion of limb arteries) diagnosed by physical exam/lab evidence and/or appropriate imaging studies (duplex ultrasound, venography, ventilation-perfusion scan, venouse or arterial angiography, MRI/MRA, catheterization.)

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Medicines Company: lead

Study Sites (1)

The Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Thrombocytopenia; Thrombosis; Heart Diseases

Interventions

bivalirudin; Anticoagulants

Condition Hierarchy (Ancestors)

Blood Platelet Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Cytopenia; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Hematologic Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Toval Rothschild, Ph.D.

  The Medicines Company

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2003
• First Posted: November 27, 2003
• Study Start: October 1, 2003
• Primary Completion: September 1, 2005
• Last Updated: November 30, 2018

Record last verified: 2018-11

Locations

US (1)