Anticoagulant Therapy With Bivalirudin in the Performance of Percutaneous Coronary Intervention in Patients With Heparin-Induced Thrombocytopenia (AT BAT, First Inning)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
The Medicines Company
ClinicalTrials.gov Identifier:
NCT00043940
First received: August 14, 2002
Last updated: September 15, 2011
Last verified: September 2011
  Purpose

Primary Objective:

To assess the safety of bivalirudin as an alternative anticoagulant therapy for patients with new or previous heparin-induced thrombocytopenia (HIT) / heparin-induced thrombocytopenia and thrombosis syndrome (HITTS) undergoing percutaneous coronary intervention (PCI). This will be measured by the composite incidence of major bleeding events during administration or within 48 hours after stopping bivalirudin (or at hospital discharge, whichever occurs first). The components of the composite endpoint are: a) intracranial bleeding; b) retroperitoneal bleeding; c) bleeding that results in hemodynamic compromise; d) bleeding that requires transfusion of three or more units of whole blood or packed red cells; and e) a decrease in hemoglobin of greater than or equal to g/dL or in hematocrit of greater than or equal to 9%.

Secondary Objectives:

Each component of the primary composite endpoint.

To evaluate the level of anticoagulation achieved with bivalirudin. The goal is to achieve an activated clotting time (ACT) between 300 and 350 sec during PCI and 4-hour bivalirudin infusion.

To evaluate bivalirudin's effects on platelet counts.


Condition Intervention Phase
Heparin-Induced Thrombocytopenia
Thrombosis
Drug: bivalirudin
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Anticoagulant Therapy With Bivalirudin in the Performance of PCI in Patients With Heparin-Induced Thrombocytopenia

Resource links provided by NLM:


Further study details as provided by The Medicines Company:

Primary Outcome Measures:
  • Major bleeding events [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]
    composite incidence of major bleeding events during administration or within 48 hours after stopping bivalirudin


Enrollment: 50
Study Start Date: April 1999
Primary Completion Date: February 2003 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: bivalirudin
    Bivalirudin therapy will be given as a 0.75-mg/kg intravenous bolus and 1.75-mg/kg/h intravenous infusion during procedure and up to 4 hours.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

INCLUSION:

  • Males and females at least 18 years of age,
  • Be able to provide written informed consent,
  • Need anticoagulation for percutaneous coronary intervention (angioplasty, rotational atherectomy, directional coronary atherectomy, transluminal extraction catheter, or coronary stent),
  • New diagnosis or history of clinically suspected or objectively documented HIT/HITTS, defined as:

(A) Positive heparin-induced platelet aggregation (HIPA) or other functional assay, defined as: (B) HIT: Thrombocytopenia associated with heparin therapy, where the platelet count: (i) has decreased to <100x10(9)/L (minimum of 30% drop from the platelet count before heparin treatment), OR (ii) has decreased to <150x10(9)/L (minimum of 40% drop from the platelet count before heparin treatment, OR, (C) HITTS: Thrombocytopenia (as defined above) PLUS arterial or venous thrombosis (deep-vein thrombosis, pulmonary embolism, mesenteric venous or arterial thrombosis, acute myocardial infarction, left ventricular thrombus, ischemic stroke, or occlusion or limb arteries), diagnosed by physical exam/lab evidence and/or appropriate imaging studies (duplex ultrasound, venography, ventilation-perfusion scan, venous or arterial angiography, MRI/MRA, catheterization).

EXCLUSION:

  • Overt or known active significant bleeding,
  • Definitive evidence of an alternative explanation for the thrombocytopenia (e.g.m DIC, sepsis, other consumptive coagulopathy, ITP, TTP, HUS, or bone-marrow failure),
  • Coagulation disorder or bleeding diathesis unrelated to HIT/HITTS,
  • Patients with renal impairment, defined as calculated creatinine clearance <30 mL/min, or any other medical conditions (including hepatic, pulmonary, gastrointestinal, endocrine, or psychiatric) that, in the investigator's opinion, would endanger the patient if she/he receives anticoagulant therapy,
  • Nonhemorrhagic stroke within the past 6 months or any previous hemorrhagic stroke,
  • Intracranial neoplasm, or cerebral/spinal arteriovenous malformation or aneurysm,
  • Lumbar puncture, or spinal/epidural catheter placement within the past 7 days,
  • Known prior hemorrhage (gastrointestinal, genitourinary, pericardia, pleural, retroperitoneal spaces), major surgery, or serious trauma within the past 6 weeks, unless attending physician believes the need for anticoagulation with PCI outweighs the potential bleeding risk,
  • Puncture of a non-compressible vessel within 24 hours before the planned PCI,
  • Confirmed uncontrolled hypertension (systolic blood pressure > or = 100 mmHg) at study entry,
  • Ongoing anticoagulant therapy at study entry. However, patients may be entered if the therapy can be safely stopped periprocedurally, or, in the case of oral warfarin, if the prothrombin time INR can safely be brought to < or = 1.5 just before study drug infusion,
  • Known or suspected pregnancy, or breast-feed. Women of childbearing potential must have a negative pregnancy test (urine or blood) and must be made explicitly aware that bivalirudin may cause excessive menstrual bleeding. Known or suspected pregnancy, or breast-feeding,
  • Known hypersensitivity to bivalirudin or leech proteins,
  • If the patient has participated in a drug trial within the past 48 hour, call the DCRI hotline.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00043940

Locations
United States, North Carolina
Duke Clinical Research Institute, Duke University Medical Center
Durham, North Carolina, United States
Sponsors and Collaborators
The Medicines Company
  More Information

No publications provided

Responsible Party: The Medicines Company
ClinicalTrials.gov Identifier: NCT00043940     History of Changes
Other Study ID Numbers: TMC-98-10
Study First Received: August 14, 2002
Last Updated: September 15, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by The Medicines Company:
thrombosis
bivalirudin
direct thrombin inhibitor
HIT
HITTS
HIT/HITTS

Additional relevant MeSH terms:
Thrombocytopenia
Thrombosis
Blood Platelet Disorders
Hematologic Diseases
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Bivalirudin
Anticoagulants
Hirudins
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Fibrinolytic Agents
Fibrin Modulating Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on September 22, 2014