Aggrastat Truncated Length Against Standard Therapies in Percutaneous Coronary Intervention (ATLAST-PCI)

Medicure

Status and phase: Withdrawn; Phase 3

Conditions: Percutaneous Coronary Intervention; Unstable Angina; Acute Coronary Syndromes; Myocardial Infarction

Treatments: Drug: Placebo; Drug: Tirofiban (Aggrastat)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01245725

10002

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups, including a placebo group

Tirofiban (Aggrastat)

Experimental group

Treatment:

Drug: Tirofiban (Aggrastat)

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo