ST-Elevation Myocardial InfarctionPhase 4NCT01158846
Bivalirudin/Prasugrel Versus Abciximab/Clopidogrel in Patients Presenting With STEMI
A Phase 4 study testing prasugrel/bivalirudin and clopidogrel/abciximab in people with ST-Elevation Myocardial Infarction and Primary Percutaneous Coronary Intervention, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
Trial summary
In the setting of ST elevation myocardial infarction newer therapies has been recently studied and, following encouraging results, introduced into the clinical practice. Prasugrel showed to be a valid alternative to overcome limitation of clopidogrel therefore providing a better ischemic protection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ST-Elevation Myocardial Infarction, Primary Percutaneous Coronary Intervention
- What is being tested?
- prasugrel/bivalirudin and clopidogrel/abciximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 1 siteItaly
- Study dates
- Aug 2010to Jun 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- ST elevation myocardial infarction
- No contraindication to primary PCI
Who cannot join
- Known intolerance/allergy to one of the study drugs or their components
- Clinical indication to treatment with oral anticoagulant, including use of warfarin or dabigatran or other oral anticoagulant agents
Trial locations and contacts
1 site in 1 country.
Italy1 site
Istituto Clinico S. Ambrogio
Milan, 20149
Luca Testa, MD, PhD, +39-3490808660, luctes@gmail.com
Luca Testa, Md, PhD
About this study
Official title: Bivalirudin Plus Prasugrel vs Abciximab Plus Clopidogrel. Optimizing Ischemic Protection and Bleeding Risk in Patients With ST Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention
In the setting of ST elevation myocardial infarction newer therapies has been recently studied and, following encouraging results, introduced into the clinical practice. Prasugrel showed to be a valid alternative to overcome limitation of clopidogrel therefore providing a better ischemic protection. On the other hand, bivalirudin is at least as beneficial as heparin/abciximab as anticoagulant agent but associated with fewer hemorrhagic events. The primary hypothesis of the study is that the combination of prasugrel plus bivalirudin can be associated with a better risk/benefit profile.
Read the detailed description
Background:
In the setting of STEMI, adjunctive pharmacological therapy plays a key role in the acute management. Along with the clear benefit of mechanical reperfusion strategies, several drugs showed to be beneficial. On top of clopidogrel, heparins and IIB/IIIa glycoprotein, other drugs have been recently introduced showing encouraging results. These "new" drugs, namely prasugrel and bivalirudin, have only been compared separately.
Primary hypothesis: the combination of prasugrel/bivalirudin is superior to the combination of clopidogrel and heparin/abciximab in terms of net adverse clinical events, i.e. ischemic events plus hemorrhagic events
Setting:
- patients presenting with ST-elevation myocardial infarction undergoing primary PCI
Mechanical reperfusion:
-primary percutaneous coronary intervention
Pharmacological Interventions:
- Two arms: Clopidogrel plus heparin/abciximab vs Prasugrel plus Bivalirudin
Follow up:
- 1 year
Measurements:
- efficacy end points in terms of reduction of ischemic events
- safety end points in terms of reduction of bleeding events
- Being tested
- prasugrel/bivalirudin, clopidogrel/abciximab
- Keywords
- STEMI, Primary PCI, anticoagulants, antiplatelets
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prasugrel/bivalirudinDrug
Also called Efient, Angiox
60mg loading dose followed by 10mg or 5 mg (according to body weight or age)maintenance dose of prasugrel. Bivalirudin during the primary PCI (bolus plus infusion)
clopidogrel/abciximabDrug
Also called Plavix, ReoPro
600mg loading dose of clopidogrel followed by 75mg maintenance dose. Abciximab will be used during primary PCI, bolus plus infusion.
| Study group | Role | What they receive |
|---|---|---|
| prasugrel/bivalirudin | Active comparator | 60 mg loading dose of prasugrel will be followed by maintenance dose of 10mg (or 5mg according to body weight and age). During primary PCI, Bivalirudin will be used as anticoagulant (bolus plus infusion), on a weight-adjusted dose. Receives: Drug: prasugrel/bivalirudin |
| clopidogrel/abciximab | Active comparator | 600mg loading dose of clopidogrel will be followed by 75mg maintenance dose. During primary PCI abciximab (bolus plus infusion) will be used as anticoagulant. Receives: Drug: clopidogrel/abciximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
major adverse cardiovascular events
Combined outcome of overall death, non fatal MI, major stroke
Measured: 1 year
Secondary outcomes (6)
major bleedings
according to TIMI major bleedings definition
Measured: 1 year
minor bleedings
according to TIMI minor bleedings definition
Measured: 1 year
stent thrombosis
according to ARC definition of probable/definite stent thrombosis
Measured: 1 year
overall death
Measured: 1 year
non fatal myocardial infarction
defined according to current guidelines
Measured: 1 year
ischemic stroke
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2010 (estimated)
- Study startAug 2010
- Primary completionJun 2011 (estimated)
- Study completionJun 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ST-Elevation Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
- Sponsor type
- University, hospital or other
- Collaborators
- Centro Cardiologico Monzino, Azienda Ospedaliera Niguarda Cà Granda, Istituto Clinico Humanitas
- Investigators
- Luca Testa, MD,PhD, Principal investigator, Istituto Clinico S. AmbrogioFracensco Bedogni, MD, Study director, Istituto Clinico S. Ambrogio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01158846
- Sponsor's protocol ID
- Biva/Pra versus Abcix/clop
- Other IDs
- B/P vs A/C for STEMI, Biva/Pra versus Abcix/clop, Biva/Pra versus Abcix/clop
- Status last verified
- Jun 2010
- First submitted
- 25 Jun 2010
- Last updated
- 8 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Montalescot G, Wiviott SD, Braunwald E, Murphy SA, Gibson CM, McCabe CH, Antman EM; TRITON-TIMI 38 investigators. Prasugrel compared with clopidogrel in patients undergoing percutaneous coronary intervention for ST-elevation myocardial infarction (TRITON-TIMI 38): double-blind, randomised controlled trial. Lancet. 2009 Feb 28;373(9665):723-31. doi: 10.1016/S0140-6736(09)60441-4.
PubMed 19249633Mehran R, Lansky AJ, Witzenbichler B, Guagliumi G, Peruga JZ, Brodie BR, Dudek D, Kornowski R, Hartmann F, Gersh BJ, Pocock SJ, Wong SC, Nikolsky E, Gambone L, Vandertie L, Parise H, Dangas GD, Stone GW; HORIZONS-AMI Trial Investigators. Bivalirudin in patients undergoing primary angioplasty for acute myocardial infarction (HORIZONS-AMI): 1-year results of a randomised controlled trial. Lancet. 2009 Oct 3;374(9696):1149-59. doi: 10.1016/S0140-6736(09)61484-7. Epub 2009 Aug 28.
PubMed 19717185
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bivalirudin Plus Prasugrel vs Abciximab Plus Clopidogrel. Optimizing Ischemic Protection and Bleeding Risk in Patients With ST Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT01158846
- Acronym / sponsor ID
- Biva/Pra versus Abcix/clop
- Keywords
- STEMI, Primary PCI, anticoagulants, antiplatelets
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioUniversity, hospital or other
- Collaborators
- Centro Cardiologico Monzino, Azienda Ospedaliera Niguarda Cà Granda, Istituto Clinico Humanitas
- Study start
- Aug 2010
- Primary completion
- Jun 2011 (estimated)
- Study completion
- Jun 2011 (estimated)
- First posted
- 8 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In the setting of ST elevation myocardial infarction newer therapies has been recently studied and, following encouraging results, introduced into the clinical practice. Prasugrel showed to be a valid alternative to overcome limitation of clopidogrel therefore providing a better ischemic protection. On the other hand, bivalirudin is at least as beneficial as heparin/abciximab as anticoagulant agent but associated with fewer hemorrhagic events. The primary hypothesis of the study is that the combination of prasugrel plus bivalirudin can be associated with a better risk/benefit profile.
Detailed description
Background:
In the setting of STEMI, adjunctive pharmacological therapy plays a key role in the acute management. Along with the clear benefit of mechanical reperfusion strategies, several drugs showed to be beneficial. On top of clopidogrel, heparins and IIB/IIIa glycoprotein, other drugs have been recently introduced showing encouraging results. These "new" drugs, namely prasugrel and bivalirudin, have only been compared separately.
Primary hypothesis: the combination of prasugrel/bivalirudin is superior to the combination of clopidogrel and heparin/abciximab in terms of net adverse clinical events, i.e. ischemic events plus hemorrhagic events
Setting:
- patients presenting with ST-elevation myocardial infarction undergoing primary PCI
Mechanical reperfusion:
-primary percutaneous coronary intervention
Pharmacological Interventions:
- Two arms: Clopidogrel plus heparin/abciximab vs Prasugrel plus Bivalirudin
Follow up:
- 1 year
Measurements:
- efficacy end points in terms of reduction of ischemic events
- safety end points in terms of reduction of bleeding events
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| prasugrel/bivalirudin | Active comparator | Drug: prasugrel/bivalirudin60 mg loading dose of prasugrel will be followed by maintenance dose of 10mg (or 5mg according to body weight and age). During primary PCI, Bivalirudin will be used as anticoagulant (bolus plus infusion), on a weight-adjusted dose. |
| clopidogrel/abciximab | Active comparator | Drug: clopidogrel/abciximab600mg loading dose of clopidogrel will be followed by 75mg maintenance dose. During primary PCI abciximab (bolus plus infusion) will be used as anticoagulant. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ST elevation myocardial infarction
- No contraindication to primary PCI
Key exclusion criteria (2 listed)
- Known intolerance/allergy to one of the study drugs or their components
- Clinical indication to treatment with oral anticoagulant, including use of warfarin or dabigatran or other oral anticoagulant agents
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 |
|---|---|---|
| prasugrel/bivalirudinAlso: Efient, Angiox60mg loading dose followed by 10mg or 5 mg (according to body weight or age)maintenance dose of prasugrel. Bivalirudin during the primary PCI (bolus plus infusion) | Drug | prasugrel/bivalirudin |
| clopidogrel/abciximabAlso: Plavix, ReoPro600mg loading dose of clopidogrel followed by 75mg maintenance dose. Abciximab will be used during primary PCI, bolus plus infusion. | Drug | clopidogrel/abciximab |
Primary outcome
major adverse cardiovascular events
Time frame: 1 year
Combined outcome of overall death, non fatal MI, major stroke
6 secondary outcomes
major bleedings
Time frame: 1 year
minor bleedings
Time frame: 1 year
stent thrombosis
Time frame: 1 year
overall death
Time frame: 1 year
non fatal myocardial infarction
Time frame: 1 year
ischemic stroke
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2010.
- Background: PubMed 19249633Montalescot G, Wiviott SD, Braunwald E, Murphy SA, Gibson CM, McCabe CH, Antman EM; TRITON-TIMI 38 investigators. Prasugrel compared with clopidogrel in patients undergoing percutaneous coronary intervention for ST-elevation myocardial infarction (TRITON-TIMI 38): double-blind, randomised controlled trial. Lancet. 2009 Feb 28;373(9665):723-31. doi: 10.1016/S0140-6736(09)60441-4.
- Background: PubMed 19717185Mehran R, Lansky AJ, Witzenbichler B, Guagliumi G, Peruga JZ, Brodie BR, Dudek D, Kornowski R, Hartmann F, Gersh BJ, Pocock SJ, Wong SC, Nikolsky E, Gambone L, Vandertie L, Parise H, Dangas GD, Stone GW; HORIZONS-AMI Trial Investigators. Bivalirudin in patients undergoing primary angioplasty for acute myocardial infarction (HORIZONS-AMI): 1-year results of a randomised controlled trial. Lancet. 2009 Oct 3;374(9696):1149-59. doi: 10.1016/S0140-6736(09)61484-7. Epub 2009 Aug 28.
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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.
Luca Testa, MD,PhD principal investigator
Istituto Clinico S. Ambrogio
Fracensco Bedogni, MD study director
Istituto Clinico S. Ambrogio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing prasugrel/bivalirudin and clopidogrel/abciximab in people with ST-Elevation Myocardial Infarction and Primary Percutaneous Coronary Intervention, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 8 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Luca Testa, MD, PhD (+39-3490808660, luctes@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
major adverse cardiovascular events (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01158846, which also lists 2 linked publications.
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 8 Jul 2010.