Completed

Angiomax in Patients With HIT/HITTS Type II Undergoing Off-PUMP CABG

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What is being tested

Data Collection

Who is being recruted

Cytopenia+6

+ Blood Platelet Disorders

+ Cardiovascular Diseases

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: October 2003
See protocol details

Summary

Principal SponsorThe Medicines Company
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: October 1, 2003

Actual date on which the first participant was enrolled.

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.

Official TitleAngiomax in Patients With HIT/HITTS Type II Undergoing Off-PUMP CABG 
NCT00073580
Principal SponsorThe Medicines Company
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

88 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

CytopeniaBlood Platelet DisordersCardiovascular DiseasesHeart DiseasesHematologic DiseasesThrombocytopeniaThrombosisVascular DiseasesEmbolism and Thrombosis

Criteria

Inclusion: * 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: 1. Positive heparin-induced platelet aggregation (HIPA) or other functional assay for HIT or immunoassay for HIT antibodies (ELISA), AND/OR 2. HIT: Thrombocytopenia associated with heparin therapy, where the platelet count has decreased by 50%, OR 3. 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.) 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 Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

The Cleveland Clinic

Cleveland, United StatesSee the location
CompletedOne Study Center