Viewing Study NCT00476944



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Last Modification Date: 2024-10-26 @ 9:33 AM
Study NCT ID: NCT00476944
Status: UNKNOWN
Last Update Posted: 2007-05-22
First Post: 2007-05-18

Brief Title: Comparing Bivalirudin Versus Heparin GP IIBIIA in Patients Undergoing PCI
Sponsor: Gold Herman K MD
Organization: Gold Herman K MD

Study Overview

Official Title: Minimizing Post-Procedural Vascular Complications Comparing Bivalirudin Versus HeparinGP IIBIIA in Patients Undergoing Percutaneous Coronary Intervention
Status: UNKNOWN
Status Verified Date: 2007-05
Last Known Status: RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: No
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 IIBIIIA use versus 2 heparin Gp IIBIIIA eptifibatide Integrilin use
Detailed Description: Anti-thrombotic therapies have enhanced the safety of percutaneous coronary intervention PCI In addition to aspirin heparin and platelet glycoprotein Gp IIBIIIA receptor inhibition have been used as the reference strategy to reduce the incidence of ischemic complications during coronary interventions 1 However the success of this strategy is limited by increased bleeding risk prolonged drug infusions 12 hours and patient inconveniences such as lying flat for hours until blood coagulation becomes normal and sheaths can be safely removed Peri-procedural bleeding due to vascular complications is one of the most frequent complications of PCI and is associated with adverse events 2

Newer anti-thrombotic strategies may further improve outcomes after PCI The efficacy of a direct thrombin inhibitor bivalirudin Angiomax was investigated in a randomized controlled clinical trial as a replacement for the strategy of heparinGp IIBIIIA inhibition in patients undergoing coronary intervention The REPLACE-2 study which randomized over 6000 patients found short and long-term clinical outcomes with bivalirudin were as effective as heparinGp IIBIIIA inhibition combination with evidence of significantly less major and minor bleeding 3 4 This led to approval of the 075 mgkg175 mgkghr dose of Angiomax by the Food and Drug Administration for use as an anticoagulant in patients with unstable angina undergoing PCI

It is now routinely accepted that early sheath removal after PCI reduces femoral access site complications and leads to earlier ambulation earlier discharge improved patient satisfaction 5 Heparin-based anticoagulation requires monitoring of the coagulation status to determine readiness for sheath removal because of the lack of predictable duration of anticoagulation with heparin Because clearance of bivalirudin occurs mostly by proteolytic cleavage by thrombin the drug has more predictable pharmacokinetics and exhibits linear dose relationship with respect to plasma concentrations and coagulation assay endpoints 6 Preliminary studies indicate sheath removal 2 hours after cessation of bivalirudin without coagulation monitoring is safe 5 While REPLACE-2 suggested that catheterization related vascular complications were decreased with bivalirudin specific data on these endpoints and others such as time to ambulation and time to discharge were not collected because of the blinded nature of the trial Currently the rate of vascular complications at MGH for patients undergoing PCI is 40 which significantly exceeds the national rate of 19 95 CI 11 to 32 7

We will conduct a randomized clinical trial in patients undergoing PCI to compare the rates of vascular related complications between patients assigned to one of two arms 1 bivalirudin provisional Gp IIBIIIA use versus 2 heparin Gp IIBIIIA eptifibatide Integrilin use The primary endpoint will be a composite of vascular related groin complications MAVE-major adverse vascular endpoints as defined in next section Secondary endpoints will be 1 time to sheath pull 2 time to ambulation and 3 occurrence of major and minor bleeding peri-catheterization

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None