EUCTR2021-005499-20-DE招募中1 期
COMPARE STEMI ONE- 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. - Compare Stemi One
Research Maatschap Cardiologen Rotterdam Zuid0 个研究点目标入组 1,656 人开始时间: 2022年8月9日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 1,656
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Inclusion Criteria at index procedure
- •All STEMI patients who are planned to be treated with PCI providing a witnessed oral informed consent:
- •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
- •Compliance to DAPT with no regimen modifications (Non-adherence Academic Research Consortium 0; see section 6.4.4)
- •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%.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 828
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 828
排除标准
- •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, willing to have pregnancy during the study period 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
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