Comparing Bivalirudin Versus Heparin/ GP IIB/IIA in Patients Undergoing PCI

NCT00476944 | Unknown Phase 4

• 1 other identifier: 2006P000944
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the rates of vascular related complications in patients undergoing percutaneous coronary intervention assigned to one of two arms: 1) bivalirudin + provisional Gp IIB/IIIA use versus 2) heparin + Gp IIB/IIIA (eptifibatide (Integrilin®)) use.

Conditions

Coronary Artery Disease

Keywords

CAD; Coronary Artery Disease; Angiomax; Bivalirudin; PCI; MAVE; Heparin

Outcome Measures

Primary Outcomes (4)

• Number of patients who require a vascular groin ultrasound or abdominal CT.

• Record occurrence of pseudoaneurysm, arteriovenous fistula, retroperitoneal hematoma, or femoral vein or arterial thrombosis

• Record presence of hematoma and size if applicable.

• Record hemoglobin drop >3g/dl with over bleeding. Also, record any red cell transfusion due to catheterization related bleeding.

Secondary Outcomes (3)

• Comparison of time to ambulation.

• Occurrence of major and minor bleeding peri-catheterization.

• Observe incidence of thrombocytopenia post catheterization defined as a platelet count <100,000.

Interventions

Percutaneous Coronary Intervention (PCI) PROCEDURE

Eligibility Criteria

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

You may qualify if:

• Patients must meet ALL of the following criteria:
• The patients must be \>18 years of age
• Patients must have been referred for percutaneous coronary intervention (PCI)
• Diagnosis of angina pectoris defined by Canadian Cardiovascular Society Classification (CCS I, II, III, IV) OR unstable angina pectoris (Braunwald Classification B\&C, I-II-III) OR patients with documented silent ischemia;
• Treatment of lesions in native coronary vessels or bypass grafts requiring angioplasty or stenting.
• Patient is willing to comply with the specified follow-up evaluation;
• Patient must provide written informed consent prior to the procedure using a form that is approved by the local Institutional Review Board.

You may not qualify if:

• Patients will be excluded if ANY of the following conditions apply:
• Patient has experienced an ST-segment elevation myocardial infarction within the preceding 24 hours.
• Active internal bleeding or bleeding diathesis, surgery, trauma, or gastrointestinal or genitourinary tract bleeding within past 6 weeks; prior intracranial bleeding; or platelet count\<100,000
• Woman of child-bearing potential unless demonstrated negative pregnancy test
• End Stage Renal Disease requiring hemodialysis
• Recipient of heart transplant;
• Current treatment with 1) intravenous unfractionated heparin or treatment with low molecular weight heparin within past 8 hours; 2)bivalirudin; 3)abciximab; 4)eptifibatide; or tirofiban
• Ongoing need for warfarin or heparin therapy
• Known allergies to aspirin, clopidogrel bisulfate (Plavix®) and/or heparin;
• Any significant medical condition which in the investigator's opinion may interfere with the patient's optimal participation in the study;
• Currently participating in an investigational drug or another device study;
• Any contraindication to glycoprotein IIb/IIIa inhibitor (eptifibatide (Integrilin®)) or bivalirudin therapy;
• Chronic or relapse/remitting hemolytic condition or pre-catheterization hematocrit\<30 mg/dl
• Unprotected left main coronary disease with \>50% stenosis;
• Platelet count \<150,000

Sponsors & Collaborators

• Gold, Herman K., MD: lead
• The Medicines Company: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Herman K Gold, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maureen Daher, RN

CONTACT

617-726-7400; MDAHER@PARTNERS.ORG

Jae S Oh, BSc

CONTACT

617-643-0456; JSOH@PARTNERS.ORG

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: INDIV

Study Record Dates

• First Submitted: May 18, 2007
• First Posted: May 22, 2007
• Study Start: September 1, 2006
• Last Updated: May 22, 2007

Record last verified: 2007-05

Locations

US (1)