Comparison Of Reduced DAPT Followed by P2Y12 Inhibitor Monotherapy With Prasugrel vs stAndard Regimen in STEMI Patients
Study Details
Study Description
Brief Summary
The study is a multi-centre, Open-label, Randomized Controlled, 1:1 trial comparing Prasugrel-based short DAPT (30-45 days) followed by Prasugrel monotherapy versus standard DAPT regimen in STEMI patients in terms of safety and efficacy endpoints.
In the subgroup of STEMI patients with MVD, a sub-randomization will allow a comparison between a complete revascularization OCT-guided versus complete revascularization angiography-guided stent in terms of efficacy and safety endpoints.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Detailed Description
Consecutive patients with STEMI planned for pPCI will be screened for eligibility criteria and treated as per standard of care with ASA and Prasugrel 60 mg loading dose. The culprit lesion will be treated during the index procedure. Non culprit lesions in patients with MVD will be treated during staged procedure(s), in any case last instalment of staged procedure(s) should be scheduled within 15 days after index procedure. Complete revascularization of non culprit lesions will be allocated to either OCT- or angio-guided strategy (OCT randomization). At 30-45 days follow-up after index procedure, if inclusion criteria are met, patients will be randomized to prasugrel monotherapy or standard DAPT regimen (DAPT randomization).
The follow-up duration is 35 months after DAPT randomization, i.e. clinical outcomes will be analysed at 11, 15 and 35 months.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Prasugrel-based short DAPT Prasugrel-based short DAPT (30-45 days) followed by Prasugrel monotherapy for 11 months. |
Drug: Prasugrel based short DAPT
Prasugrel-based short DAPT (30-45 days) followed by Prasugrel monotherapy versus
|
| Active Comparator: Prasugrel based standard DAPT Prasugrel-based DAPT for 1 year |
Drug: Prasugrel based standard DAPT
Prasugrel based DAPT for 1 year
|
| Experimental: OCT guided non-culprit lesion Complete revascularization of non culprit lesions guided by OCT |
Device: OCT guided revascularization
OCT guided revascularization of the non-culprit lesions
|
| Active Comparator: Angio guided non-culprit lesion Complete revascularization of non culprit lesions guided by Angio |
Device: Angio guided revascularization
Angio guided revascularization of the non-culprit lesions
|
Outcome Measures
Primary Outcome Measures
- non inferiority of a Prasugrel-based short DAPT (30-45 days) followed by Prasugrel 11 month monotherapy versus standard 12 month DAPT regimen [11 months]
Incidence of Net Adverse Clinical Events (NACE) at 11 months post DAPT randomization as composite of all cause death, MI, stroke or BARC bleeding 3 or 5
- superiority of an Optical Coherence Tomography (OCT)-guided revascularization completion as compared to a standard angiography-guided revascularization completion. [immediately after the procedure]
Post-procedural Minimal Stent Area (MSA)
Secondary Outcome Measures
- Composite of MACCE [3 year]
Composite of the number of major adverse cardiac and cerebrovascular events (MACCE) defined as cardiovascular death, myocardial infarction, or ischaemic stroke
- BARC type 3 or 5 events [1 and 3 years]
Number of BARC type 3 or 5 events occuring
Eligibility Criteria
Criteria
Inclusion Criteria:
Eligibility at index procedure
All STEMI patients who are planned to be treated with PCI:
ST segment elevation myocardial infarction
Chest discomfort suggestive of cardiac ischemia ≥20 min at rest, within 24 h prior to randomization with 1 of the following ECG features:
-
ST segment elevation ≥2 contiguous ECG leads
-
new or presumably new left bundle branch block
In patients with multivessel disease, treatment only of the culprit lesion / target vessel during primary PCI is recommended.
Eligibility at 30-45 days
-
All patients who have provided informed consent
-
Compliance to DAPT with no regimen modifications (Non-adherence Academic Research Consortium 0)
-
No occurrence of significant event (such as MI, unplanned revascularisation, stent thrombosis, stroke, major vascular complication/bleeding BARC Types 3 or greater).
-
Successful revascularization: - Successful delivery and deployment of the Study device(s), with final residual stenosis of <30% (visually) for all target lesions.
-
Complete revascularization performed when more than 1 significant lesion, during the index procedure or in staged procedure(s) occurring within 15 days from the index procedure. Physiologic assessment highly recommended for lesions with stenosis between 50% and 90%.
Exclusion Criteria:
-
Patients on oral anticoagulation
-
Contraindication to P2Y12 inhibitors (hypersensitivity, history of any stroke or transient ischemic attack within the last 12 months, active bleeding, fibrin-specific fibrinolytic therapy less than 24 h before randomization, chronic renal insufficiency requiring dialysis, moderate or severe hepatic dysfunction)
-
Patients who have received P2Y12 inhibitors other than Prasugrel in the ambulance (Ticagrelor or Clopidogrel loading dose) or are already on P2Y12 inhibitors, may be enrolled in the protocol, provided that the Prasugrel loading dose is administered at admission, according to current guidelines recommendations (see section 5.2.2).
-
Concomitant oral or i.v. therapy with strong CYP3A inhibitors (e.g., ketoconazole, itraconazole, voriconazole, telithromycin, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir, grapefruit juice >1L/day), CYP3A substrates with narrow therapeutic indices (e.g., cyclosporine, quinidine), or strong CYP3A inducers (e.g., rifampin)
-
rifampicin, phenytoin, carbamazepine, dexamethasone, phenobarbital
-
Platelet count <100.000/μL at the time of screening
-
Anemia (hemoglobin <10 g/dL) at the time of screening
-
Comorbidities associated with life expectancy <1 year
-
Pregnancy, giving birth within the last 90 days, or lactation
-
PCI indication for stent thrombosis or previous history of definite stent thrombosis
-
Non-deferrable major surgery on DAPT after PCI
-
Cardiogenic shock
-
Out of hospital cardiac arrest (OHCA)
-
No informed consent
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Albert Schweitzer ziekenhuis | Dordrecht | Netherlands | ||
| 2 | Erasmus Medical Center | Rotterdam | Netherlands | ||
| 3 | Maasstadziekenhuis | Rotterdam | Netherlands |
Sponsors and Collaborators
- Research Maatschap Cardiologen Rotterdam Zuid
- Abbott Medical Devices
Investigators
- Principal Investigator: Valeria Paradies, MD, PhD, Research Maatschap Cardiologen Rotterdam Zuid
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RM21