Aggrastat Truncated Length Against Standard Therapies in Percutaneous Coronary Intervention

Phase 3

Withdrawn

• Conditions: Myocardial Infarction; Unstable Angina; Percutaneous Coronary Intervention; Acute Coronary Syndromes
• Interventions: Drug: Tirofiban (Aggrastat); Drug: Placebo

• Registration Number: NCT01245725
• Lead Sponsor: Medicure

Brief Summary

The purpose of this study is to determine whether the efficacy of tirofiban (a 25mcg/kg i.v. bolus followed by a 0.15mcg/kg/min i.v. infusion during a percutaneous coronary intervention (PCI) plus two hours after the procedure) is more effective than placebo in the setting of standard therapies (e.g. aspirin, a thienopyridine, and unfractionated heparin or bivalirudin) among patients undergoing PCI, as assessed by the incidence of adverse cardiac ischemic events defined as death, myocardial infarction (MI), and urgent target vessel revascularization (uTVR) within 48 hours following study drug initiation.

A secondary objective of this study is to assess whether tirofiban (a 25mcg/kg i.v. bolus followed by a 0.15mcg/kg/min i.v. infusion during a PCI plus two hours after the procedure) is safe compared to placebo in the setting of standard therapies (e.g. aspirin, a thienopyridine, and unfractionated heparin or bivalirudin) among patients undergoing PCI, as assessed by the incidence of non-CABG-related TIMI major bleeding within 48 hours following study drug initiation.

Patient enrollment is pending.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-11-12
• Study First Submitted QC: 2010-11-19
• Study First Posted: 2010-11-22
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-09
• Last Update Posted: 2018-03-13

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Age >18 years of age
2. Scheduled to undergo PCI with an approved device
3. Written informed consent

Exclusion Criteria

1. Primary PCI for ST-elevation myocardial infarction (STEMI)
2. Prior PCI within 30 days
3. Prior GPIIb/IIIa use within 14 days
4. Prior enoxaparin use within 4 days
5. Prior STEMI within 30 days
6. In non-elective subjects, a rising troponin defined as a most recent pre-PCI sample greater than the sample immediately preceding it, as long as the two samples are separated by four or more hours and have been analyzed in the same hospital laboratory.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tirofiban (Aggrastat)	Tirofiban (Aggrastat)	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
A composite incidence of death, myocardial infarction and urgent target vessel revascularization.	48 hours

Secondary Outcome Measures

Name	Time	Method
The occurrence of myocardial infarction.	48 hours