Clinical Trials Logo

Clinical Trial Summary

This study is a randomized, double-blind, multi-center study designed to compare differences in rates of myonecrosis (measured as an elevation of CK-MB ratio ≥ 2 times ULN) within 24 hours following low-medium risk percutaneous coronary intervention (PCI) in aspirin or clopidogrel non-responsive patients who are randomized to heparin with or without eptifibatide therapy during PCI. The primary objective of this study is to determine if the use of eptifibatide is associated with a significant difference in post-PCI myonecrosis (measured as an elevation of CK-MB ratio ≥ 2 times upper limit of normal [ULN]) within 24 hours of low-medium risk PCI in patients who are aspirin or non-responsive as determined by VerifyNow Aspirin and P2Y12 testing.


Clinical Trial Description

The primary objective of this study is to determine if the use of eptifibatide is associated with a significant difference in post-PCI myonecrosis (measured as an elevation of CK-MB ratio ≥ 2 times upper limit of normal [ULN]) within 24 hours of low-medium risk PCI in patients who are aspirin or clopidogrel non-responsive as determined by VerifyNow Aspirin and P2Y12 testing.

Secondary study objectives will include an assessment of safety. These safety determinations will be determined by monitoring the rates of MACE (defined as death, MI, ischemic [non-hemorrhagic] stroke and urgent revascularization by repeat PCI or CABG), bleeding events, rate of bailout procedures performed, elevations of CK-MB ratio (in the range of 3 to 5 times ULN and greater than 5 times ULN) and elevations of troponin I.

This study is a randomized, double-blind, multi-center study designed to compare differences in rates of myonecrosis (measured as an elevation of CK-MB ratio ≥ 2 times ULN) within 24 hours following low-medium risk percutaneous coronary intervention (PCI) in aspirin or clopidogrel non-responsive patients who are randomized to heparin with or without eptifibatide therapy during PCI. All subjects must also be pretreated with clopidogrel (300-600 mg) at least 2 hours before PCI. Study subjects will be randomized to either eptifibatide and unfractionated heparin or unfractionated heparin and placebo. Study subject randomization in aspirin non-responsive patients will be stratified based upon clopidogrel responsiveness. ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00289601
Study type Interventional
Source Brigham and Women's Hospital
Contact
Status Terminated
Phase Phase 4
Start date March 2006
Completion date December 2007

See also
  Status Clinical Trial Phase
Completed NCT02837744 - Studying Hemostatic Effect of Axiostat® Dressing on Radial Access After Percutaneous Procedure
Completed NCT02214082 - Safety of Same Day Discharge After Elective Percutaneous Coronary Intervention N/A
Recruiting NCT00370578 - Aspiration Device in Myocardial Infarction Trial N/A
Recruiting NCT02276846 - Palpitate-Eluting Balloon Angioplasty in the Treatment of Coronary Bifurcation Lesion Evaluated by OCT N/A
Recruiting NCT01080638 - Intracoronary Bolus Only Compared With Intravenous Bolus and 12-hours Infusion of Abciximab in Non-ST Elevation Myocardial Infarction. Phase 4
Completed NCT03673254 - Evaluation of Practices and Prognostic Factors of Percutaneous Coronary Interventions (PCI) of Calcified Complex Lesions Using Rotational Atherectomy Device.
Completed NCT01249027 - XIENCE V Everolimus Eluting Coronary Stent System (EECSS) China: Post-Approval, Single-Arm Study
Completed NCT01180517 - The Paclitaxel-Eluting Percutaneous Coronary Angioplasty (PTCA)-Balloon Catheter for the Treatment of Coronary Bifurcations Phase 4
Completed NCT00399646 - Evaluation of the Metricath Gemini System, a Device Intended to Make Arterial Measurements and Perform Angioplasty Dilations. Phase 2
Recruiting NCT05113407 - Observatory on the Use of the Shockwave Medical C2 Coronary Lithotripsy System in the General Population in France.
Completed NCT04445480 - Popliteal Block for Lower Limb Angioplasty N/A
Completed NCT02722213 - Mindfulness & Stress Management Study for Cardiac Patients N/A
Completed NCT00858715 - Resistance to Antithrombotic Therapy N/A
Recruiting NCT04325867 - Integrated Distance Management Strategy for Patients With Cardiovascular Diseases in the Context of COVID-19 N/A
Completed NCT01174472 - Drug Eluting Balloon Angioplasty for Dialysis Access Treatment Phase 2/Phase 3
Completed NCT00715416 - PTA vs. Primary Stenting of SFA Using Self-Expandable Nitinol Stents Phase 4
Terminated NCT00437905 - Balloon Angioplasty vs. Cutting Balloon Angioplasty of Femoropopliteal Arteries- a Randomized Controlled Trial Phase 4
Completed NCT01894152 - XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS) China Single-Arm Study
Completed NCT00808717 - Efficacy of High Dose atorvaSTATIN Loading Before Primary Percutaneous Coronary Intervention in ST Elevation Myocardial Infarction (STATIN STEMI) Phase 4
Completed NCT03388892 - Drug-Eluting Balloon in Arteriovenous Graft N/A