- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00073580
Angiomax in Patients With HIT/HITTS Type II Undergoing Off-Pump Coronary Artery Bypass Grafting (CABG) (CHOOSE)
November 29, 2018 updated by: The Medicines Company
Angiomax in Patients With HIT/HITTS Type II Undergoing Off-PUMP CABG
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
88
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ohio
-
Cleveland, Ohio, United States, 44195
- The Cleveland Clinic
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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:
- 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.)
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Primary Endpoint
Time Frame: 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.
|
7 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Toval Rothschild, Ph.D., The Medicines Company
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2003
Primary Completion (ACTUAL)
September 1, 2005
Study Registration Dates
First Submitted
November 26, 2003
First Submitted That Met QC Criteria
November 26, 2003
First Posted (ESTIMATE)
November 27, 2003
Study Record Updates
Last Update Posted (ACTUAL)
November 30, 2018
Last Update Submitted That Met QC Criteria
November 29, 2018
Last Verified
November 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Hematologic Diseases
- Embolism and Thrombosis
- Blood Platelet Disorders
- Heart Diseases
- Thrombosis
- Thrombocytopenia
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Fibrinolytic Agents
- Fibrin Modulating Agents
- Protease Inhibitors
- Antithrombins
- Serine Proteinase Inhibitors
- Bivalirudin
- Anticoagulants
- Hirudins
Other Study ID Numbers
- TMC-BIV-02-02
- CHOOSE
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Thrombosis
-
Università degli Studi dell'InsubriaOttawa Hospital Research InstituteUnknownPortal Vein Thrombosis | Mesenteric Vein Thrombosis | Splenic Vein ThrombosisCanada, Italy
-
University of MaltaUniversità degli Studi dell'InsubriaRecruitingCerebral Vein Thrombosis | Renal Vein Thrombosis | Retinal Vein Thrombosis | Splanchnic Vein Thrombosis | Ovarian Vein ThrombosisThailand, Spain, United States, Italy, Slovenia, France, Israel, Canada, Malta, Netherlands
-
Capital Medical UniversityBeijing Municipal Science & Technology CommissionNot yet recruitingCerebral Venous Sinus Thrombosis | Deep Cerebral Vein Thrombosis | Cortical Vein Thrombosis
-
University of AlbertaSanofi; Edmonton Civic Employees Research FundTerminatedPortal Vein Thrombosis | Splenic Vein ThrombosisCanada
-
Academic and Community Cancer Research UnitedNational Cancer Institute (NCI)CompletedDeep Vein Thrombosis | Venous Thromboembolism | Pulmonary Embolism | Malignant Neoplasm | Portal Vein Thrombosis | Metastatic Malignant Neoplasm | Cerebral Vein Thrombosis | Renal Vein Thrombosis | Gonadal Thrombosis | Hepatic Thrombosis | Mesenteric Thrombosis | Splenic ThrombosisUnited States
-
Assiut UniversityNot yet recruitingPortal Vein Thrombosis
-
Azienda Ospedaliera Universitaria PoliclinicoCompletedDeep Vein ThrombosisItaly
-
University of OklahomaPfizerCompleted
-
Fondazione Policlinico Universitario Agostino Gemelli...RecruitingSplanchnic Vein ThrombosisItaly
-
University Hospital, GenevaSunnybrook Health Sciences CentreNot yet recruitingDeep Vein Thrombosis
Clinical Trials on Angiomax (bivalirudin) anticoagulant
-
The Medicines CompanyCompletedMyocardial Infarction | Acute Disease | Unstable AnginaUnited States
-
The Medicines CompanyCompletedMyocardial InfarctionUnited States
-
The Medicines CompanyCompletedCardiovascular Disease | Coronary Artery Bypass SurgeryUnited States
-
The Medicines CompanyCompleted
-
Children's Hospital Los AngelesBaylor College of Medicine; Children's Hospital of Philadelphia; Children's Hospital... and other collaboratorsCompletedDeep Venous ThrombosisUnited States
-
NycomedWithdrawn
-
Qian GongUnknownCoronary Heart Disease
-
NYU Langone HealthGuerbetCompletedCoronary Artery DiseaseUnited States
-
Johns Hopkins UniversityWithdrawnExtracorporeal Membrane Oxygenation ComplicationUnited States