Comparison Of reduced DAPT followed by P2Y12 inhibitor Monotherapy with Prasugrel vs stAndard Regimen in STEMI patients treated with OCT-guided vs aNgio-guided completE revascularization.

Recruiting

Conditions: ST elevated myocard infarct
10011082

Registration Number: NL-OMON54076

Lead Sponsor: Maasstadziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 600

Inclusion Criteria

Inclusion Criteria 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 with 1 of the
following ECG features:
• ST segment elevation >=2 contiguous ECG leads
• new or presumably new left bundle branch block

Inclusion Criteria 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 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 and/or to Cardioaspirin or to any of the
excipients (hypersensitivity, history of any stroke or transient ischemic
attack within the last 12 months, active bleeding or haemorrhagic diathesis,
fibrin-specific fibrinolytic therapy less than 24 h before randomization,
severe hepatic dysfunction (Child-Pugh C), history of asthma induced by the
administration of salicylates or substances with a similar action, notably
non-steroidal anti-inflammatory medicines, history of gastrointestinal
perforation or acute gastrointestinal ulcers, severe cardiac failure (NYHA
grade III or IV), combination with methotrexate at doses of 15 mg/week or
more).
- 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, dexamethason, 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 (see appendix
III for women of childbearing potential)
- 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) unless survivors of ventricular
arrythmia with prompt return of spontaneous circulation (ROSC)
- Patients with severe renal impairment: creatinine clearance <=30 ml/min/1.73
m2 (as calculated by MDRD formula for estimated GFR).
- Patients participating in another interventional (device of drug trial)
within the previous 12 months or patients to whom an investigational drug was
administered in the 30 days prior to screening, or 5 half-lives of the study
drug, whichever is longer.
- No informed consent

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The first primary objective of this Open-label, Randomized, Controlled Clinical<br /><br>Trial is to demonstrate the non inferority of a Prasugrel-based short DAPT<br /><br>(30-45 days) followed by 11-month Prasugrel monotherapy versus standard DAPT<br /><br>regimen by assessing:<br /><br>- Incidence of Net Adverse Clinical Events (NACE) at 11 months post DAPT<br /><br>randomization as composite of death, MI, stroke or BARC bleeding 3 or 5<br /><br><br /><br>The co-primary objective is to demonstrate in patients with multivessel disease<br /><br>the superiority of an Optical Coherence Tomography (OCT)-guided<br /><br>revascularization completion as compared to a standard angiography-guided<br /><br>revascularization completion by assessing:<br /><br>- Post-procedural Minimal Stent Area (MSA) </p><br>

Secondary Outcome Measures