Myocardial InfarctionPhase 2SAVI-PCINCT01522417
Shortened Aggrastat® Versus Integrilin in Percutaneous Coronary Intervention
A Phase 2 study testing Short Tirofiban, Eptifibatide and Long Tirofiban in people with Myocardial Infarction and Acute Coronary Syndromes, run by Medicure at 13 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction, Acute Coronary Syndromes, Unstable Angina
- What is being tested?
- Short Tirofiban, Eptifibatide and Long Tirofiban
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 535 participants
- Where
- 13 sitesUnited States
- Study dates
- Apr 2012to Mar 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Emory University Hospital Midtown
Atlanta, Georgia, 30308
Emory University Hospital
Atlanta, Georgia, 30322
Doylestown Hospital
Doylestown, Pennsylvania, 18901
North Georgia Heart Center
Gainesville, Georgia, 30501
Osceola Regional Medical Center
Kissimmee, Florida, 34741
Centennial Heart
Nashville, Tennessee, 37203
Lenox Hill Hospital
New York, New York, 10075
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, 19104
Chippenham Hospital
Richmond, Virginia, 23225
Redmond Regional Medical Center
Rome, Georgia, 30165
Northside Hospital
St. Petersburg, Florida, 33709
Archbold Medical Center
Thomasville, Georgia, 31792
About this study
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
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.
- Being tested
- Short Tirofiban, Eptifibatide, Long Tirofiban
- Medical subject headings
- Myocardial Infarction, Acute Coronary Syndrome, Angina, Unstable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short TirofibanDrug
Also called Aggrastat
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.
EptifibatideDrug
Also called Integrilin
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.
Long TirofibanDrug
Also called Aggrastat
25 mcg/kg i.v. bolus followed by a 0.15 mcg/kg/min i.v. infusion for 12 to 18 hours post-PCI.
| Study group | Role | What they receive |
|---|---|---|
| Short Tirofiban (Aggrastat) | Experimental | 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). Receives: Drug: Short Tirofiban |
| Eptifibatide (Integrilin) | Active comparator | 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). Receives: Drug: Eptifibatide |
| Long Tirofiban (Aggrastat) | Experimental | Tirofiban (Aggrastat) will be dosed as a 25 mcg/kg i.v. bolus followed by a 0.15 mcg/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 (50 U/kg and repeat dosing per protocol guidelines). Receives: Drug: Long Tirofiban |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Composite Endpoint of Death, Periprocedural Myonecrosis (PPM), Urgent Target Vessel Revascularization (uTVR) or Major Bleeding
The composite of death (any-cause), periprocedural myonecrosis (defined as ≥ 3 times the upper limit of normal troponin and at least 20% or greater than the baseline troponin value), urgent target revascularization (repeat PCI or any CABG procedure after the index PCI on a non-selective basis in the target vessel because of recurrent myocardial ischemia) or non-CABG related major bleeding as quantified according to REPLACE-2 bleeding criteria.
Measured: 48 hours or hospital discharge, whichever came first
Secondary outcomes (4)
The Composite Endpoint of Death, Periprocedural Myonecrosis or Urgent Target Vessel Revascularization
The composite of death (any-cause), periprocedural myonecrosis (defined as ≥ 3 times the upper limit of normal troponin and at least 20% or greater than the baseline troponin value), or urgent target revascularization (repeat PCI or any CABG procedure after the index PCI on a non-selective basis in the target vessel because of recurrent myocardial ischemia)
Measured: 48 hours or hospital discharge, whichever came first
Individual Components of Death, Urgent Target Revascularization or Major Bleeding
Individual components of death (any-cause), urgent target revascularization (repeat PCI or any CABG procedure after the index PCI on a non-selective basis in the target vessel because of recurrent myocardial ischemia) or non-CABG related major bleeding as quantified according to REPLACE-2 major bleeding criteria.
Measured: 48 hours or hospital discharge, whichever came first
Individual Components of Periprocedural Myonecrosis
Individual components of periprocedural myonecrosis (PPM) (defined as ≥ 3 times, ≥ 10 times, ≥ 20 times or ≥ 50 times the upper limit of normal troponin and at least 20% or greater than the baseline troponin value)
Measured: 48 hours or hospital discharge, whichever came first
The Composite Endpoint of Death, Periprocedural Myonecrosis (PPM) (≥ 10x Troponin), Urgent Target Vessel Revascularization (uTVR) or Major Bleeding
The composite of death (any-cause), periprocedural myonecrosis (defined as ≥ 10 times the upper limit of normal troponin and at least 20% or greater than the baseline troponin value), urgent target revascularization (repeat PCI or any CABG procedure after the index PCI on a non-selective basis in the target vessel because of recurrent myocardial ischemia) or non-CABG related major bleeding as quantified according to REPLACE-2 bleeding criteria.
Measured: 48 hours or hospital discharge, whichever came first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2012 (estimated)
- Study startApr 2012
- Primary completionDec 2018
- Study completionMar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 535 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medicure
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- SCRI Development Innovations, LLC
- Responsible party
- Sponsor
- Investigators
- Steven V Manoukian, MD, Principal investigator, SCRI Development Innovations, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01522417
- Sponsor's protocol ID
- Medicure 11002
- Acronym
- SAVI-PCI
- Status last verified
- Apr 2021
- First submitted
- 27 Jan 2012
- Last updated
- 13 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01522417
- Acronym / sponsor ID
- SAVI-PCI / Medicure 11002
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 535 participants (actual)
- Lead sponsor
- MedicureIndustry (pharma, biotech, devices)
- Collaborators
- SCRI Development Innovations, LLC
- Study start
- Apr 2012
- Primary completion
- Dec 2018 (actual)
- Study completion
- Mar 2019 (actual)
- First posted
- 31 Jan 2012 (estimated)
- Results
- Posted 20 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Short Tirofiban (Aggrastat) | Experimental | Drug: Short TirofibanTirofiban (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). |
| Eptifibatide (Integrilin) | Active comparator | Drug: EptifibatideEptifibatide (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). |
| Long Tirofiban (Aggrastat) | Experimental | Drug: Long TirofibanTirofiban (Aggrastat) will be dosed as a 25 mcg/kg i.v. bolus followed by a 0.15 mcg/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 (50 U/kg and repeat dosing per protocol guidelines). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Short TirofibanAlso: Aggrastat25 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. | Drug | Short Tirofiban (Aggrastat) |
| EptifibatideAlso: Integrilin180 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. | Drug | Eptifibatide (Integrilin) |
| Long TirofibanAlso: Aggrastat25 mcg/kg i.v. bolus followed by a 0.15 mcg/kg/min i.v. infusion for 12 to 18 hours post-PCI. | Drug | Long Tirofiban (Aggrastat) |
Primary outcome
The Composite Endpoint of Death, Periprocedural Myonecrosis (PPM), Urgent Target Vessel Revascularization (uTVR) or Major Bleeding
Time frame: 48 hours or hospital discharge, whichever came first
The composite of death (any-cause), periprocedural myonecrosis (defined as ≥ 3 times the upper limit of normal troponin and at least 20% or greater than the baseline troponin value), urgent target revascularization (repeat PCI or any CABG procedure after the index PCI on a non-selective basis in the target vessel because of recurrent myocardial ischemia) or non-CABG related major bleeding as quantified according to REPLACE-2 bleeding criteria.
4 secondary outcomes
The Composite Endpoint of Death, Periprocedural Myonecrosis or Urgent Target Vessel Revascularization
Time frame: 48 hours or hospital discharge, whichever came first
Individual Components of Death, Urgent Target Revascularization or Major Bleeding
Time frame: 48 hours or hospital discharge, whichever came first
Individual Components of Periprocedural Myonecrosis
Time frame: 48 hours or hospital discharge, whichever came first
The Composite Endpoint of Death, Periprocedural Myonecrosis (PPM) (≥ 10x Troponin), Urgent Target Vessel Revascularization (uTVR) or Major Bleeding
Time frame: 48 hours or hospital discharge, whichever came first
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven V Manoukian, MD principal investigator
SCRI Development Innovations, LLC
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Short Tirofiban, Eptifibatide and Long Tirofiban in people with Myocardial Infarction and Acute Coronary Syndromes, run by Medicure at 13 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Composite Endpoint of Death, Periprocedural Myonecrosis (PPM), Urgent Target Vessel Revascularization (uTVR) or Major Bleeding (time frame: 48 hours or hospital discharge, whichever came first). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2021; AzTrials last refreshed its copy on 6 Nov 2026.