NL-OMON54076招募中不适用
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
Maasstadziekenhuis0 个研究点目标入组 600 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 600
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
- 年龄范围
- 18 至 99（—）
入选标准
- •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
- •Successful revascularization: - Successful delivery and deployment of the
- •Study device(s), with final residual stenosis of <30% (visually) for all target
- •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%
排除标准
- •- 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
- •- 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
- •- 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
研究者
相似试验
进行中（未招募）
1 期
Assessment of Loading with the P2Y12 inhibitor Ticagrelor or clopidogrel to Halt ischemic Events in patients Undergoing elective coronary Stenting: the ALPHEUS study.PCI-related myocardial infarction (MI type 4) or injury (I) within 48 hours (or at hospital discharge if earlier than 48 hours) of elective PCI/stentMedDRA version: 20.0Level: PTClassification code 10028596Term: Myocardial infarctionSystem Organ Class: 10007541 - Cardiac disordersEUCTR2015-000850-39-CZASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)1,900
招募中
不适用
4D-ACS studyKCT0006992Gachon University Gil Medical Center1,128
进行中（未招募）
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.ST elevated myocard infarction followed by PCIEUCTR2021-005499-20-NLResearch Maatschap Cardiologen Rotterdam Zuid1,656
进行中（未招募）
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.St-Elevated Myocardial InfartionCTIS2024-515883-30-00Research Maatschap Cardiologen Rotterdam Zuid1,200
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.EUCTR2021-005499-20-DEResearch Maatschap Cardiologen Rotterdam Zuid1,656