EUCTR2006-002618-37-FR进行中（未招募）1 期
A Randomized, Double-Blind, Cross-Over Study Comparing the Pharmacodynamic Response in Subjects with Acute Coronary Syndrome Receiving 14 Days 10-mg Maintenance Dose Prasugrel (LY640315) versus 14 Days 150-mg Maintenance Dose Clopidogrel After Using a 900-mg Loading Dose of Clopidogrel to Reduce Ongoing Platelet Activation – The ACAPULCO Study - ACAPULCO Study
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 70
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 syndrome (ACS) based on the disease diagnostic criteria and have planned treatment, as part of standard of care, with a one-time 900-mg loading dose of commercially available clopidogrel.
- •[2] Are of a legal age (and at least 18 years of age to less than 85 years of age) and competent mental condition to provide written informed consent before entering the study. Informed consent must be signed by the study participant or authorized representative, according to local rules and regulations.
- •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
- •[4] Have overt ST-segment elevation myocardial infarction (STEMI).
- •[5] Have cardiogenic shock (systolic blood pressure <90 mmHg associated with clinical evidence of end-organ hypoperfusion, or subjects requiring vasopressors to maintain systolic blood pressure over 90 mmHg and associated with clinical evidence of end-organ hypoperfusion).
- •[6] Have refractory ventricular arrhythmias.
- •[7] Have New York Heart Association (NYHA) Class IV congestive heart failure (CHF; see Attachment TABN.3 for NYHA CHF classifications).
- •[8] Have severe and uncontrolled hypertension.
- •Bleeding Risk Exclusion Criteria
- •[9] Have fibrin-specific fibrinolytic therapy planned within the 24-hour period prior to randomization.
- •[10] Have nonfibrin-specific fibrinolytic therapy planned within the 48-hour period prior to randomization.
- •[11] Have active internal bleeding or history of bleeding diathesis.
- •[12] Have clinical findings, in the judgment of the investigator, associated with an increased risk of bleeding.
- •[13] Have any of the following:
- •a) Prior history of hemorrhagic stroke.
- •b) Intracranial neoplasm, arteriovenous malformation, or aneurysm.
- •c) Ischemic stroke =3 months prior to Visit 1.
- •[14] Known International Normalized Ratio (INR) of >1.5.
- •[15] Have a platelet count of <100,000/mm3.
- •[16] Have anemia (hemoglobin [Hgb] <10 gm/dL).
- •Prior/Concomitant Therapy Exclusion Criteria
- •[17] Have received any GPIIb/IIIa inhibitors less than 30 days prior to study entry or anytime during the study.
- •[18] Are receiving or will receive oral anticoagulation or other antiplatelet therapy (other than aspirin, low molecular weight heparin, or hirudin) that cannot be safely discontinued for the duration of the study.
- •[19] Are currently receiving chemotherapy or radiation therapy.
- •General Exclusion Criteria
- •[20] 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.
- •[21] Are employed by Eli Lilly & Company, Daiichi Sankyo, Inc., or the contract research organization (CRO) (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.
- •[22] Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry, or are presently enrolled in another drug or device study.
- •[23] Have previously completed or withdrawn from this study or any other study investigating prasugrel.
- •[24] Are women who are known to be pregnant, who have given birth within the past 90 days, who are breastfeeding, or of child-bearing potential who test negative for pregnancy at Visit 1 , but refuse to use a reliable method of birth control (that is barrier, hormonal, or abstinence) during the study.
- •[25] Have a concomitant medical illness (for example, terminal malignancy) that in the opinion of the investigator is associated with reduced survival over the next 15 months.
- •[26] Have any other condition, chronic illness, or medication that, in the opinion of the investigator, would preclude participation in the
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