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Anticoagulant
Eptifibatide + Bivalirudin vs Bivalirudin for Coronary Artery Disease
Phase 4
Waitlist Available
Led By Paul A Gurbel, MD
Research Sponsored by LifeBridge Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subjects (men or women) aged ³ 18
Patients undergoing elective coronary stenting (200 patients)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is comparing two different treatments for people getting coronary stents, to see which one results in better outcomes.
Who is the study for?
This trial is for adults over 18 undergoing elective coronary stenting who haven't had a severe heart attack or stroke recently, major surgery within the last six weeks, bleeding disorders, certain drug treatments, or very low blood counts. Pregnant women and those not using contraception are excluded.Check my eligibility
What is being tested?
The study compares two treatment regimens for preventing clot formation during coronary stent implantation: one combines high-dose clopidogrel with bivalirudin and eptifibatide; the other uses high-dose clopidogrel with bivalirudin alone. Outcomes will be tracked for up to a year.See study design
What are the potential side effects?
Potential side effects may include increased risk of bleeding, allergic reactions to medications used in the regimens (e.g., eptifibatide), bruising at injection sites, and possibly others related to anti-clotting therapies.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I am scheduled for elective coronary stenting.
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
Compare the antiplatelet effects of clopidogrel+bivalirudin vs. clopidogrel+bivalirudin+eptifibatide in patients undergoing elective percutaneous intervention
Secondary outcome measures
Assess in-hospital 30 day, and 1 year clinical outcomes.
Compare the release of myocardial necrosis and inflammatory markers
Measure platelet reactivity with conventional light transmittance aggregometry and thrombelastography
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Who is running the clinical trial?
LifeBridge HealthLead Sponsor
28 Previous Clinical Trials
4,168 Total Patients Enrolled
8 Trials studying Coronary Artery Disease
2,567 Patients Enrolled for Coronary Artery Disease
Paul A Gurbel, MDPrincipal InvestigatorPlatelet and Thrombosis Research L.L.C
4 Previous Clinical Trials
535 Total Patients Enrolled
2 Trials studying Coronary Artery Disease
400 Patients Enrolled for Coronary Artery Disease
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't taken Plavix or Ticlid in the last 14 days.I am currently taking warfarin.I had a severe heart attack within the last 2 days.I have experienced a severe failure of my heart to pump blood.I haven't taken any platelet GPIIb/IIIa inhibitors in the last 30 days.I have had a bleeding stroke before or any stroke/TIA within the last 30 days.I have not had major surgery in the last 6 weeks.Your blood platelet count is less than 100,000 per cubic millimeter.Your hematocrit level is less than 25%.I am not allergic to eptifibatide, heparin, aspirin, or plavix.I am 18 years old or older.My kidney function is reduced with high creatinine or low clearance.I am scheduled for elective coronary stenting.I had a heart stent placed within the last 4 weeks or have one planned soon.I have not taken any low molecular weight heparin in the last 12 hours.You have a history of alcohol or drug abuse.You have more than 50% blockage in your main left coronary artery.I haven't had unusual bleeding or a bleeding disorder in the last month.Your blood clotting time is more than 1.5 times the normal level.
Research Study Groups:
This trial has the following groups:Awards:
This trial has 3 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- 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.
Does one need to be under 30 years of age in order to partake in this experiment?
"This clinical trial can only include patients aged 18 to 65. There are 27 trials specifically designed for minors, while those over the age of retirement may participate in 836 different studies."
Answered by AI
Is enrollment open for this research study?
"The clinicaltrials.gov portal does not indicate that this medical trial is accepting new patients at the moment. Initially posted on March 1st 2006 and last updated August 29th of the same year, current enrolment is closed; however, there are 847 other trials actively recruiting now."
Answered by AI
What has been the government's evaluation of this therapy?
"With a score of 3 on our team's 1-3 scale, this treatment can be considered safe because it is at the Phase 4 stage, signifying that it has been authorized by regulatory bodies."
Answered by AI
What type of person would be best suited to participate in this trial?
"In order to be considered for this trial, potential participants should have coronary artery disease and must lie within the age range of 18-65. Approximately 200 individuals are needed in total."
Answered by AI
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