NL-OMON47836已完成4 期
Ticagrelor or prasugrel versus clopidogrel in elderly patients with an acute coronary syndrome and a high bleeding risk: optimization of antiplatelet treatment in high-risk elderly - POPular AGE
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 1,000
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
- •1) At least 70 years of age.
- •2) Hospitalization for NSTEMI or unstable angina according to the criteria of the ESC guideline.
排除标准
- •1) Contraindication to P2Y12 inhibitors i.e. clopidogrel, prasugrel or ticagrelor:
- •- Hypersensitivity to the active substance or to any of the excipients.
- •- History of intracranial bleeding or active pathological bleeding such as peptic ulcer or intracranial haemorrhage.
- •- Moderate to severe (Child-Pugh C) hepatic dysfunction.
- •- Use of strong CYP3A4 inhibitors (i.e. itraconazole, voriconazole, ketoconazole, erytromycin, clarithromycin, rifampicin, nefozodone, lopinavir, carbamazepine, fenytoïne, fenobarbital, ritonavir en atazanavir).
- •2) Unable or unwilling to give informed consent or have a life expectancy of less than one year.
- •3) Having received thrombolytic therapy within the previous 24 hours.
- •4) Severe renal function impairment needing dialysis.
- •5) Confirmed or persistent severe hypertension (Systolic Blood Pressure (SBP) > 180 mmHg and/or Diastolic Blood Pressure (DBP) >110 mmHg) at randomization.
- •6) At increased bleeding risk, at the investigator*s opinion, i.e. because of malignancy.
- •7) Cardiogenic shock (SBP * 80mmHg for >30 mins) or Intra-Aortic Balloon Pump (IABP) at the time of screening.
- •8) History of major surgery, severe trauma, fracture or organ biopsy within 90 days prior to randomisation.
- •9) Clinically significant out of range values for platelet count or haemoglobin at screening, in the investigator*s opinion.
- •10) ACS under dual antiplatelet therapy, e.g. aspirin with a P2Y12 inhibitor; clopidogrel, prasugrel, ticagrelor.
- •11) Patients with a known CYP2C19 genotype at the time of randomization.
研究者
相似试验
尚未招募
不适用
Ticagrelor of prasugrel versus clopidogrel bij ouderepatiënten met een acuut coronair syndroom (pijn op deborst en hartinfarct) en een hoog bloedingsrisico:Optimaliseren van bloedplaatjes remming bij ouderenmet verhoogd bloedingsrisicoAnti-platelet therapy in the elderly with Non ST elevation acute coronary syndrome and CRUSADE score of at least 31NL-OMON21629St. Antonius teaching hospital1,000
进行中（未招募）
不适用
Ticagrelor or prasugrel versus clopidogrel in elderly patients with an acute coronary syndrome and a high bleeding risk: optimization of antiplatelet treatment in high-risk elderlyMyocardial infarction with Non-ST-segment elevation (NSTEMI) and unstable angina (UA).EUCTR2013-001403-37-NLSt. Antonius Hospital
进行中（未招募）
1 期
Comparison of ticagrelor and clopidogrel in patients with diabetes mellitus and ischemic heart diseaseEUCTR2014-001661-27-ESSociedad Española de Cardiología
进行中（未招募）
不适用
Endothelial Funkction after Stenting.Coronary artery diseaseMedDRA version: 16.1Level: PTClassification code 10011078Term: Coronary artery diseaseSystem Organ Class: 10007541 - Cardiac disordersEUCTR2011-005305-73-DEniversity Medical Center of the Johannes Gutenberg-University Mainz
招募中
2 期
Comparing the efficacy of Ticagrelor and Clopidogrel in patients with Acute ischemic attack or Transient ischemic attack(TIA)Cerebral infarctionIRCT20130311012781N6Ahvaz University of Medical Sciences424