Shortened Aggrastat® Versus Integrilin in Percutaneous Coronary Intervention (SAVI-PCI)
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ClinicalTrials.gov Identifier: NCT01522417 |
Recruitment Status
:
Recruiting
First Posted
: January 31, 2012
Last Update Posted
: March 12, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Myocardial Infarction Acute Coronary Syndromes Unstable Angina | Drug: Short Tirofiban Drug: Eptifibatide Drug: Long Tirofiban | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 550 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (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 |
Study Start Date : | April 2012 |
Estimated Primary Completion Date : | March 2019 |
Estimated Study Completion Date : | July 2019 |

Arm | Intervention/treatment |
---|---|
Experimental: Short 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 post-PCI. 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: Short 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 post-PCI.
Other Name: Aggrastat
|
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.
Other Name: Integrilin
|
Experimental: Long Tirofiban (Aggrastat)
(Enrolment Completed) Tirofiban (Aggrastat) will be dosed as a 25 ug/kg i.v. bolus followed by a 0.15 ug/kg/min i.v. infusion for 12 to 18 hours post PCI. Patients will receive tirofiban (Aggrastat) on a background of dual oral anti-platelet agents and unfractionated heparin (50U/kg and repeat dosing per protocol guidelines). |
Drug: Long Tirofiban
25 ug/kg i.v. bolus followed by a 0.15 ug/kg/min i.v. infusion for 12 to 18 hours post-PCI.
Other Name: Aggrastat
|
- The composite incidence of death, PCI-related myocardial infarction, urgent target vessel revascularization or major bleeding [ Time Frame: 48 hours ]
- The composite incidence of death, PCI-related myocardial infarction or urgent target vessel revascularization [ Time Frame: 48 hours ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age ≥18 years of age
- Scheduled to undergo PCI with an FDA, approved or cleared device (stent or procedures such as balloon angioplasty, rotoblation, AngioSculpt, laser atherectomy,etc.) in one or more native coronary 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01522417
Contact: Debbie Douglas, PhD | 204-594-3624 | ddouglas@medicure.com |
United States, Florida | |
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Kissimmee, Florida, United States, 34741 | |
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Atlanta, Georgia, United States, 30308 | |
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Gainesville, Georgia, United States, 30501 | |
Redmond Regional Medical Center | Recruiting |
Rome, Georgia, United States, 30165 | |
Principal Investigator: Hector R Picon, MD | |
Archbold Medical Center | Completed |
Thomasville, Georgia, United States, 31792 | |
United States, New York | |
Lenox Hill Hospital | Completed |
New York, New York, United States, 10075 | |
United States, Oklahoma | |
University of Oklahoma Health Sciences Center | Recruiting |
Oklahoma City, Oklahoma, United States, 73104 | |
Principal Investigator: Mazen Abu-Fadel, MD | |
United States, Pennsylvania | |
Doylestown Hospital | Completed |
Doylestown, Pennsylvania, United States, 18901 | |
Penn Presbyterian Medical Center | Completed |
Philadelphia, Pennsylvania, United States, 19104 | |
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 |
Principal Investigator: | Steven V Manoukian, MD | SCRI Development Innovations, LLC |
Responsible Party: | Medicure |
ClinicalTrials.gov Identifier: | NCT01522417 History of Changes |
Other Study ID Numbers: |
Medicure 11002 |
First Posted: | January 31, 2012 Key Record Dates |
Last Update Posted: | March 12, 2018 |
Last Verified: | March 2018 |
Additional relevant MeSH terms:
Platelet Aggregation Inhibitors Infarction Myocardial Infarction Acute Coronary Syndrome Angina, Unstable Ischemia Pathologic Processes Necrosis Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases |
Angina Pectoris Chest Pain Pain Neurologic Manifestations Nervous System Diseases Signs and Symptoms Tirofiban Eptifibatide Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action |