EUCTR2009-014176-22-DE进行中（未招募）不适用
A Comparison of Prasugrel at the Time of Percutaneous Coronary Intervention (PCI) Or as Pre-treatment At the Time of Diagnosis in Patients with Non-ST-Elevation Myocardial Infarction (NSTEMI) - The ACCOAST Study - TADF
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Eli Lilly
- 入组人数
- 4,200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •[1] Present with acute coronary syndromes (ACS) consisting of non-STsegment elevation (NSTEMI) with elevated troponin. NSTEMI is defined as a history of chest discomfort or ischemic symptoms of ?10 minutes duration at rest ?48 hours prior to entry into the study with no evidence of persistent ST-segment elevation. Elevated troponin is defined as a troponin T or I = 1.5 times the upper limit of normal (ULN).
- •[2] Are scheduled for coronary angiography/PCI =2 and <24 hours from the time of planned randomization. If necessary due to timing constraints, coronary angiography/PCI may be scheduled the next day with the intention to perform coronary angiography/PCI within 24 hours, but definitely no later than 48 hours from randomization.
- •[3] Must be eligible for treatment with prasugrel, ASA, and a GPIIb/IIIa inhibitor as per respective labels.
- •[4] May be on a maintenance dose of clopidogrel 75 mg and must be able to switch to prasugrel.
- •[5] Must be enrolled at a cardiac catheterization laboratory hospital or at a hospital/ambulance service affiliated with a cardiac catheterization laboratory hospital.
- •[6] Must be of a legal age (and at least 18 years of age) and of competent mental condition to provide written informed consent before entering the study. Informed consent must be signed by the study participant or authorized representative, if allowed by local rules and regulations.
- •[7] Must not be of child-bearing potential (1 year post-menopausal or surgically sterile).
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Cardiovascular Exclusion Criteria
- •[8] Present with STEMI at the time of entry or randomization into the study defined as follows: ST-segment elevation MI is defined as a history of chest discomfort or ischemic symptoms of >20 minutes duration at rest ?14 days prior to entry into the study with one of the following present on at least one ECG prior to randomization:
- •a) ST-segment elevation ?1 mm in two or more contiguous ECG
- •b) New or presumably new left bundle branch block (LBBB).
- •c) ST-segment depression ?1 mm in two anterior precordial leads
- •(V1 through V4) with clinical history and evidence suggestive of
- •true posterior infarction.
- •[9] Have cardiogenic shock (systolic blood pressure <90 mm Hg associated with clinical evidence of end-organ hypoperfusion, or subjects requiring vasopressors to maintain systolic blood pressure over 90 mm Hg and associated with clinical evidence of end-organ hypoperfusion).
- •[10] Have refractory ventricular arrhythmias.
- •[11] Have New York Heart Association (NYHA) Class IV congestive heart
- •failure (CHF); see Attachment TADF.3 for NYHA CHF classifications.
- •[12] Have had cardiac arrest within 1 week of entry or randomization into the study.
- •Bleeding Risk Exclusion Criteria
- •[13] Have any of the following:
- •(a) Prior history of hemorrhagic or ischemic stroke, a transient
- •ischemic attack (TIA), or sub-arachnoid hemorrhage.
- •(b) History of intracranial neoplasm, arteriovenous malformation, or aneurysm.
- •[14] Have received fibrinolytic therapy within 48 hours of entry or
- •randomization into the study.
- •[15] Have active pathological bleeding or history of bleeding diathesis.
- •[16] Have clinical findings, in the judgment of the investigator, associated with an increased risk of bleeding.
- •[17] Have known anemia.
- •[18] Have had recent surgery (within 4 weeks of entry into the study) or are scheduled to undergo surgery within the next 2 months.
- •Prior/Concomitant Therapy Exclusion Criteria
- •[19] Have received a loading dose of a thienopyridine (ticlopidine, clopidogrel or prasugrel) or a maintenance dose of prasugrel or ticlopidine within 7 days of entry into the study.
- •[20] Are receiving a GPIIb/IIIa inhibitor (eptifibatide, tirofiban, or abciximab).
- •[21] Are receiving warfarin or other coumarin derivatives.
- •[22] Are receiving or will receive oral anticoagulation or other oral antiplatelet therapy (except aspirin [ASA]) that cannot be safely discontinued within the next 3 months.
- •[23] Are receiving daily treatment with NSAIDs or COX2- inhibitors that cannot be
- •discontinued or are anticipated to require >2 weeks of daily treatment with NSAID or COX2 inhibitors during the study.
- •General Exclusion Criteria
- •[24] Are investigator site personnel directly affiliated with the study or are immediate family of investigator site personnel directly affiliated with the study. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
- •[25] Are employed by Eli Lilly & Company, Ube Industries Limited, or Daiichi Sankyo Company Limited (that is, employees, temporary contract workers, or designees responsible for the conduct of the study) Immediate family of Lilly employees may participate in Lilly-sponsored clinical studies but are not permitted to participate at a Lilly facility. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
- •[26] Have received treatment within the last 30 days with a drug tha
研究者
相似试验
进行中（未招募）
不适用
A Comparison of Prasugrel at the Time of Percutaneous Coronary Intervention (PCI) Or as Pre-treatment At the Time of Diagnosis in Patients with Non-ST-Elevation Myocardial Infarction (NSTEMI) - The ACCOAST Study - TADFAcute Coronary SyndromesMedDRA version: 12.0Level: LLTClassification code 10051592Term: Acute coronary syndromeEUCTR2009-014176-22-HUEli Lilly4,100
进行中（未招募）
1 期
A Comparison of Prasugrel at the Time of Percutaneous Coronary Intervention (PCI) Or as Pre-treatment At the Time of Diagnosis in Patients with Non-ST-Elevation Myocardial Infarction (NSTEMI) - The ACCOAST Study - TADFAcute Coronary SyndromesMedDRA version: 13.1Level: PTClassification code 10051592Term: Acute coronary syndromeSystem Organ Class: 10007541 - Cardiac disordersEUCTR2009-014176-22-BEEli Lilly4,100
进行中（未招募）
不适用
A Comparison of Prasugrel at the Time of Percutaneous Coronary Intervention (PCI) Or as Pre-treatment At the Time of Diagnosis in Patients with Non-ST-Elevation Myocardial Infarction (NSTEMI) - The ACCOAST Study - TADFAcute Coronary SyndromesMedDRA version: 14.1Level: PTClassification code 10051592Term: Acute coronary syndromeSystem Organ Class: 10007541 - Cardiac disordersEUCTR2009-014176-22-FIEli Lilly4,100
进行中（未招募）
不适用
A Comparison of Prasugrel at the Time of Percutaneous Coronary Intervention (PCI) Or as Pre-treatment At the Time of Diagnosis in Patients with Non-ST-Elevation Myocardial Infarction (NSTEMI) - The ACCOAST StudyEUCTR2009-014176-22-NLEli Lilly4,100
进行中（未招募）
1 期
A Comparison of Prasugrel at the Time of Percutaneous Coronary Intervention (PCI) Or as Pre-treatment At the Time of Diagnosis in Patients with Non-ST-Elevation Myocardial Infarction (NSTEMI) - The ACCOAST Study - TADFAcute Coronary SyndromesMedDRA version: 14.1Level: PTClassification code 10051592Term: Acute coronary syndromeSystem Organ Class: 10007541 - Cardiac disordersEUCTR2009-014176-22-CZEli Lilly4,100