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Anticoagulant
Bivalirudin vs Heparin for Coronary Artery Disease
Phase 4
Waitlist Available
Led By Herman K Gold, MD
Research Sponsored by Gold, Herman K., MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
Patients must be >18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is testing whether bivalirudin, a blood thinner, plus a second medication is better than heparin plus a different second medication at preventing vascular complications in people undergoing a heart procedure.
Who is the study for?
This trial is for adults over 18 with coronary heart disease needing angioplasty or stenting. They must have angina, unstable angina, or silent ischemia and agree to follow-up evaluations. Excluded are those with certain blood conditions, recent severe heart attacks, end-stage kidney disease, on conflicting medications, pregnant women or those who might become pregnant without a negative pregnancy test.Check my eligibility
What is being tested?
The study compares two treatments in patients having percutaneous coronary intervention (PCI): one group receives bivalirudin with provisional Gp IIB/IIIA inhibitors; the other gets heparin plus Gp IIB/IIIA inhibitor eptifibatide. The goal is to see which treatment leads to fewer vascular complications.See study design
What are the potential side effects?
Possible side effects include bleeding risks, allergic reactions to the drugs used (bivalirudin or eptifibatide), and potential issues related to intravenous drug administration like bruising at the injection site.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with chest pain due to heart issues or silent heart disease.
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I am older than 18 years.
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I have been referred for a procedure to open blocked arteries in my heart.
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I need a procedure to open blocked arteries in my heart.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of patients who require a vascular groin ultrasound or abdominal CT.
Record hemoglobin drop >3g/dl with over bleeding. Also, record any red cell transfusion due to catheterization related bleeding.
Record occurrence of pseudoaneurysm, arteriovenous fistula, retroperitoneal hematoma, or femoral vein or arterial thrombosis
+1 moreSecondary outcome measures
Comparison of time to ambulation.
Observe incidence of thrombocytopenia post catheterization defined as a platelet count <100,000.
Occurrence of major and minor bleeding peri-catheterization.
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Who is running the clinical trial?
Gold, Herman K., MDLead Sponsor
1 Previous Clinical Trials
120 Total Patients Enrolled
1 Trials studying Coronary Artery Disease
120 Patients Enrolled for Coronary Artery Disease
The Medicines CompanyIndustry Sponsor
71 Previous Clinical Trials
77,655 Total Patients Enrolled
6 Trials studying Coronary Artery Disease
16,190 Patients Enrolled for Coronary Artery Disease
Herman K Gold, MDPrincipal InvestigatorMassachusetts General Hospital
1 Previous Clinical Trials
120 Total Patients Enrolled
1 Trials studying Coronary Artery Disease
120 Patients Enrolled for Coronary Artery Disease
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently on blood thinners or have been in the last 8 hours.I am currently on warfarin or heparin therapy.I haven't had significant bleeding or a very low platelet count recently.I have been diagnosed with chest pain due to heart issues or silent heart disease.I am a woman who can have children and have a negative pregnancy test.I cannot take certain blood clot prevention medications due to health reasons.I have a long-term or recurring condition that breaks down red blood cells.I am older than 18 years.I have been referred for a procedure to open blocked arteries in my heart.I had a severe heart attack in the last 24 hours.I am on hemodialysis for end-stage kidney disease.I have a significant blockage in the main artery of my heart.Your platelet count is less than 150,000.I need a procedure to open blocked arteries in my heart.I have received a heart transplant.You are allergic to aspirin, clopidogrel bisulfate (Plavix®), or heparin.
Research Study Groups:
This trial has the following groups:Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still opportunities to take part in this investigation?
"Sadly, this clinical trial is not recruiting any more participants. The research was initially posted on September 1st 2006 and last revised May 18th 2007. Nonetheless, 571 other studies are presently advertising for volunteers in the present day."
Answered by AI
How hazardous is this medication for individuals?
"The safety rating of this treatment was determined to be a 3 due to its Phase 4 status, which reflects the fact that it has completed rigorous testing and been officially approved."
Answered by AI
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