Shortened Aggrastat® Versus Integrilin in Percutaneous Coronary Intervention (SAVI-PCI)
This study is currently recruiting participants.
Verified February 2013 by Medicure
Sponsor:
Medicure
Collaborator:
Sarah Cannon Research Institute
Information provided by (Responsible Party):
Medicure
ClinicalTrials.gov Identifier:
NCT01522417
First received: January 27, 2012
Last updated: February 13, 2013
Last verified: February 2013
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Purpose
The purpose this study is to assess whether a tirofiban regimen of a high-dose bolus plus a shortened infusion duration compared to label-dosing eptifibatide in patients undergoing percutaneous coronary intervention (PCI) is associated with a non-inferior composite rate of death, PCI-related myocardial infarction, urgent target vessel revascularization or in-hospital major bleeding within 48 hours following PCI or hospital discharge, whichever comes first.
| Condition | Intervention | Phase |
|---|---|---|
|
Myocardial Infarction Acute Coronary Syndromes Unstable Angina |
Drug: Tirofiban Drug: Eptifibatide |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Randomized, Multicenter, Open-Label Study to Evaluate the Efficacy of Tirofiban Using a High-Dose Bolus Plus a Shortened Infusion Duration Versus Label-Dosing Eptifibatide in Patients Undergoing Percutaneous Coronary Intervention |
Resource links provided by NLM:
Further study details as provided by Medicure:
Primary Outcome Measures:
- The composite incidence of death, PCI-related myocardial infarction, urgent target vessel revascularization or major bleeding [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- The composite incidence of death, PCI-related myocardial infarction or urgent target vessel revascularization [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 600 |
| Study Start Date: | April 2012 |
| Estimated Study Completion Date: | September 2014 |
| Estimated Primary Completion Date: | September 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Tirofiban (Aggrastat)
Tirofiban (Aggrastat) will be dosed as a 25 mcg/kg i.v. bolus followed by a 0.15 mcg/kg/min i.v. infusion during a PCI plus 1 to 2 hours after the procedure. Patients will receive tirofiban (Aggrastat) on a background of dual oral anti-platelet agents and unfractionated heparin (50 U/kg and repeat dosing per protocol guidelines). |
Drug: Tirofiban
25 mcg/kg i.v. bolus followed by a 0.15 mcg/kg/min i.v. infusion during a PCI plus 1 to 2 hours after the procedure.
|
|
Active Comparator: Eptifibatide (Integrilin)
Eptifibatide (Integrilin) will be dosed as a 180 mcg/kg bolus followed by a 2.0 mcg/kg/min infusion for 12 to 18 hours, with a second 180 mcg/kg bolus 10 min after the first. Patients will receive eptifibatide (Integrilin) on a background of dual oral anti-platelet agents and unfractionated heparin (50 U/kg and repeat dosing per protocol guidelines). |
Drug: Eptifibatide
180 mcg/kg bolus followed by a 2.0 mcg/kg/min infusion for 12 to 18 hours, with a second 180 mcg/kg bolus 10 min after the first.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Age >18 years of age
- Scheduled to undergo PCI with an approved device in one or more target lesions
- Written informed consent
Exclusion Criteria:
- Primary PCI for STEMI as index procedure
- Prior STEMI within 48 hours before randomization
- Prior PCI within 30 days before randomization
- Planned staged PCI within the subsequent 24 hours after index PCI
- Use of abciximab within 7 days before randomization
- Use of tirofiban or eptifibatide within 12 hours before randomization
- Use of low-molecular weight heparin within 12 hours before randomization
- Use of bivalirudin within 12 hours before randomization
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01522417
Contacts
| Contact: Sean Cahill, M Biotech | 204-928-7202 | scahill@medicure.com |
Locations
| United States, Florida | |
| Osceola Regional Medical Center | Recruiting |
| Kissimmee, Florida, United States, 34741 | |
| Principal Investigator: Patrick F Mathias, MD | |
| Northside Hospital | Recruiting |
| St. Petersburg, Florida, United States, 33709 | |
| Principal Investigator: Andrew Rosenthal, MD | |
| United States, Georgia | |
| Emory University Hospital | Recruiting |
| Atlanta, Georgia, United States, 30322 | |
| Principal Investigator: Habib Samady, MD | |
| Emory University Hospital Midtown | Recruiting |
| Atlanta, Georgia, United States, 30308 | |
| Principal Investigator: Henry A Liberman, MD | |
| Northeast Georgia Heart Center | Recruiting |
| Gainesville, Georgia, United States, 30501 | |
| Principal Investigator: J J Marshall, MD | |
| Redmond Regional Medical Center | Recruiting |
| Rome, Georgia, United States, 30165 | |
| Principal Investigator: Hector R Picon, MD | |
| Archbold Medical Center | Not yet recruiting |
| Thomasville, Georgia, United States, 31792 | |
| United States, New York | |
| Lenox Hill Hospital | Recruiting |
| New York, New York, United States, 10075 | |
| Principal Investigator: Joseph A Puma, MD | |
| United States, Oklahoma | |
| University of Oklahoma Health Sciences Center | Recruiting |
| Oklahoma City, Oklahoma, United States, 73104 | |
| Principal Investigator: Jorge F Saucedo, MD | |
| United States, Pennsylvania | |
| Doylestown Hospital | Recruiting |
| Doylestown, Pennsylvania, United States, 18901 | |
| Principal Investigator: Joseph F McGarvey, MD | |
| Penn Presbyterian Medical Center | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Principal Investigator: William H Matthai, MD | |
| United States, Tennessee | |
| Centennial Heart | Recruiting |
| Nashville, Tennessee, United States, 37203 | |
| Principal Investigator: Brian K Jefferson, MD | |
| United States, Virginia | |
| Chippenham Hospital | Recruiting |
| Richmond, Virginia, United States, 23225 | |
| Principal Investigator: Michael L Arcarese, MD | |
Sponsors and Collaborators
Medicure
Sarah Cannon Research Institute
Investigators
| Principal Investigator: | Steven V Manoukian, MD | Sarah Cannon Research Institute |
More Information
No publications provided
| Responsible Party: | Medicure |
| ClinicalTrials.gov Identifier: | NCT01522417 History of Changes |
| Other Study ID Numbers: | Medicure 11002 |
| Study First Received: | January 27, 2012 |
| Last Updated: | February 13, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Angina, Unstable Infarction Myocardial Infarction Acute Coronary Syndrome Angina Pectoris Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases Chest Pain Pain Signs and Symptoms Ischemia |
Pathologic Processes Necrosis Tirofiban Eptifibatide Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Cardiovascular Agents Therapeutic Uses Hematologic Agents Platelet Aggregation Inhibitors |
ClinicalTrials.gov processed this record on June 18, 2013