Angiomax in Patients With HIT/HITTS Type II Undergoing CPB (HIT/TS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00079508|
Recruitment Status : Completed
First Posted : March 11, 2004
Last Update Posted : November 10, 2011
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
|Condition or disease||Intervention/treatment||Phase|
|Cardiovascular Disease Coronary Artery Bypass Surgery||Drug: Angiomax (bivalirudin)||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||125 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase III Study of Angiomax (Bivalirudin) in Patients With HIT/HITTS Type II Undergoing Cardiac Surgery on Cardiopulmonary Bypass (CPB)|
|Study Start Date :||April 2004|
|Actual Primary Completion Date :||October 2005|
- Drug: Angiomax (bivalirudin)
250 mg vial administered as 1.0 mg/kg intravenous (IV) bolus and 2.5 mg/kg/h IV infusion during the procedure with the option to administer additional 0.1 to 0.5 mg/kg boluses to increase the level of anticoagulation as clinically indicated. A low-dose infusion could have been 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. A starting bolus of 0.1 mg/kg and/or an 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.
- Primary Endpoint [ Time Frame: 7 days ]In-hospital acute procedural success, defined as the absence of death, Q wave MI, repeat coronary revascularization, and stroke (hemorrhagic or ischemic) at hospital discharge or Day 7 after surgery ('Day 7/discharge'), whichever occurs first.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Provide written informed consent before initiation of any study-related procedures, and
- Be at least 18 years of age, and
- Be scheduled for CABG, CABG single valve surgery, or isolated single valve surgery on CPB. Patients undergoing repeat (redo) CABG are also considered eligible for this study, and demonstrated
New diagnosis or history of objectively documented HIT/HITTS Type II, defined as one or more of the following:
- 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 evidence of arterial or venous thrombosis
- Confirmed pregnancy at time of enrollment via IVRS (if woman of child-bearing potential) (Urine or serum pregnancy test)
- 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 prior to enrollment 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 planned cardiac surgery.
- Patients receiving 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 enrollment.
- 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 cause inability to comply with the trial.
- Planned surgical procedure in which proximal anastomoses will precede distal anastomoses of the bypass grafts.
- Planned (>1) double (or greater) valve repair-replacement (e.g.: AVR-MVR) surgery.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00079508
|United States, Ohio|
|The Cleveland Clinic|
|Cleveland, Ohio, United States, 44195|
|Study Director:||Malcolm Lloyd, MD||The Medicines Company|
|Responsible Party:||The Medicines Company|
|Other Study ID Numbers:||
|First Posted:||March 11, 2004 Key Record Dates|
|Last Update Posted:||November 10, 2011|
|Last Verified:||November 2011|
Heparin-induced Thrombocytopenia/Thrombosis Syndrome
Heparin anti-body positive
Serine Proteinase Inhibitors
Molecular Mechanisms of Pharmacological Action