Comparison of Prasugrel and Clopidogrel in Very Elderly and Non-Elderly Patients With Stable Coronary Artery Disease (GENERATIONS)
2012년 9월 27일 업데이트: Eli Lilly and Company
A Pharmacokinetic and Pharmacodynamic Comparison of Prasugrel and Clopidogrel in Very Elderly Versus Non-Elderly Aspirin-Treated Subjects With Stable Coronary Artery Disease
The 5-milligram (mg) maintenance dose (MD) of prasugrel in very elderly patients with coronary artery disease produces a pharmacodynamic response within the same therapeutic range as 10-mg MD in non-elderly patients.
연구 개요
연구 유형
중재적
등록 (실제)
155
단계
- 1단계
연락처 및 위치
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연구 장소
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Nieuwegein, 네덜란드, 3435 CM
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Florida
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Jacksonville, Florida, 미국, 32209
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Maryland
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Baltimore, Maryland, 미국, 21215
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Ohio
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Cincinnati, Ohio, 미국, 45212
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Lund, 스웨덴, 22185
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Malmo, 스웨덴, 20502
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Dublin, 아일랜드, 9
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
45년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- Participants (Either: at least 45 years of age, but less than 65 years of age OR 75 years of age or older) with a history of stable coronary artery disease who are not currently indicated for treatment with a thienopyridine (that is, prasugrel, clopidogrel, or ticlopidine)
- Provision of written informed consent
- Body weight greater than or equal to 60 kilograms (kg)
- For women of child-bearing potential only (that is, women who are not surgically or chemically sterilised and who are between menarche and 1 year post menopause), test negative for pregnancy (based on a urine or serum pregnancy test to be performed before randomisation) and agree to use a reliable method of birth control during the study
Exclusion Criteria:
- Unstable coronary artery disease
- Myocardial Infarction (MI) within the previous 30 days
- Percutaneous Coronary Intervention (PCI) or Coronary Artery Bypass Graft Surgery (CABG) within the previous 90 days
- History of refractory ventricular arrhythmias within the last 6 months; an implanted defibrillator device; congestive heart failure within 6 months prior to screening; major surgery, or severe trauma, fracture or organ biopsy within 3 months prior to enrollment
- Any planned surgical procedure or any coronary revascularisation (surgical or percutaneous) planned within 60 days following randomisation
- Any known contraindication to treatment with an antiplatelet agent
- Significant hypertension at the time of screening or randomisation
- Clinically significant out-of-range values for platelet count or haemoglobin at screening, in the investigator's opinion, or results of clinical laboratory tests at the time of screening that are judged to be clinically significant for the study population, as determined by the investigator
- Prior history or presence of significant bleeding disorders, abnormal bleeding tendency, or personal history of coagulation or bleeding disorders
- Prior history or clinical suspicion of cerebral vascular malformations, intracranial neoplasm, Transient Ischemic Attack (TIA) or stroke
- Prior history of thrombocytopenia or thrombocytosis
- Use of antiplatelet agents (besides aspirin) within 10 days prior to screening; the use (or planned use) of heparin, oral anticoagulants, or fibrinolytic agents within 30 days of screening; or participants receiving daily treatment with nonsteroidal anti-inflammatory drugs (NSAIDS) or cyclooxygenase-2 (COX-2) inhibitors that cannot be discontinued for the duration of the study
공부 계획
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연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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활성 비교기: 프라수그렐 10mg
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administered orally, daily for 12 days
다른 이름들:
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활성 비교기: 클로피도그렐 75mg
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12일 동안 매일 경구 투여
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실험적: 5 milligrams (mg) prasugrel
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administered orally, daily for 12 days
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in Maximum Platelet Aggregation (MPA) to 20 Micromoles (μM) Adenosine Diphosphate (ADP) as Measured by Light Transmission Aggregometry (LTA) From Baseline to 12 Days of Therapy in the First Treatment Period
기간: Baseline, 12 days
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Maximum Platelet Aggregation (MPA) to 20 μM ADP was assessed by light transmission aggregometry (LTA), an assay that measures platelet aggregation by determining the amount of light transmitted through a cuvette containing the platelet-rich plasma stimulated with a platelet activator, such as ADP, relative to platelet-poor plasma (100% light transmittance).
Lower MPA values reflect stronger platelet inhibition, whereas higher MPA values reflect weaker inhibition.
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Baseline, 12 days
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in Vasodilator-associated Stimulated Phosphoprotein (VASP) From Baseline to 12 Days of Therapy
기간: Baseline, Day 12
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Vasodilator-associated stimulated phosphoprotein (VASP) phosphorylation levels, expressed as the platelet reactivity index (PRI), reflect the degree of thienopyridine-mediated P2Y12 receptor inhibition.
A lower PRI reflects stronger inhibition of P2Y12, whereas a higher PRI reflects weaker inhibition of P2Y12.
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Baseline, Day 12
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Change in VerifyNow P2Y12 Reaction Units (PRU) From Baseline to 12 Days of Therapy
기간: Baseline, Day 12
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The Accumetrics VerifyNow® P2Y12 assay measures platelet aggregation in whole blood and is reported in P2Y12 reaction units (PRU).
PRU report the extent of P2Y12 receptor-mediated platelet aggregation calculated as a function of the rate and extent of platelet aggregation in the presence of adenosine phosphate ADP.
A lower PRU reflects stronger inhibition of P2Y12, whereas a higher PRU reflects weaker inhibition of P2Y12.
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Baseline, Day 12
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Active Metabolite Blood Levels to Drug Exposure as Measured by Pharmacokinetics (PK) Through 4 Hours After Dosing
기간: Baseline up to 4 hours post-dose
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A descriptive pharmacokinetic-pharmacodynamic (PK-PD) analysis comparing prasugrel and clopidogrel active metabolite exposures to MPA in response to 20 µM ADP (by LTA) was conducted as originally intended; however, the graphic output from that analysis is not possible here.
Therefore, the PK portion is presented here as AUC and the PD portion is presented in Secondary Outcome Measure #5.
AUC was calculated through the last scheduled sampling time of 4 hours [AUC (0-4)] or through the sampling time of the last quantifiable concentration prior to 4 hours.
AUC values were denoted AUC(0-tlast) in both instances.
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Baseline up to 4 hours post-dose
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Change From Baseline in Maximum Platelet Aggregation (MPA) as Measured by Light Transmission Aggregometry (LTA) From Baseline at Day 12 of Therapy
기간: Baseline, Day 12
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Maximum Platelet Aggregation (MPA) to 20 μM ADP was assessed by light transmission aggregometry (LTA), an assay that measures platelet aggregation by determining the amount of light transmitted through a cuvette containing the platelet-rich plasma stimulated with a platelet activator, such as ADP, relative to platelet-poor plasma (100% light transmittance).
A lower MPA reflects stronger platelet inhibition, whereas a higher MPA reflects weaker inhibition.
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Baseline, Day 12
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연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2010년 3월 1일
기본 완료 (실제)
2011년 10월 1일
연구 완료 (실제)
2011년 10월 1일
연구 등록 날짜
최초 제출
2010년 4월 19일
QC 기준을 충족하는 최초 제출
2010년 4월 19일
처음 게시됨 (추정)
2010년 4월 21일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2012년 10월 26일
QC 기준을 충족하는 마지막 업데이트 제출
2012년 9월 27일
마지막으로 확인됨
2012년 9월 1일
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- 12835
- H7T-MC-TACY (기타 식별자: Eli Lilly and Company)
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