- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01829659
The ACS Ethnicity Platelet Function Study
This study is being done to assess the effects of the CTP inhibitor on the function of your platelets (cells within your blood that are involved in the formation of blood clots) and to assess whether you have responded to the ticagrelor well enough to prevent the formation of blood clots within the stent or site in which angioplasty was performed.
Recent studies have looked at how racial differences can affect platelet reactivity, the way blood clots. But these studies have not looked at the way different racial backgrounds can affect the way the blood forms clots. Minorities, such as African-Americans are underrepresented. Therefore, we are conducting this platelet reactivity study to better understand if there are differences in how this drug affects African-Americans from how they affect Caucasian patients undergoing percutaneous coronary intervention and receiving ticagrelor. These data will be compared to a historical control of Caucasian patients who underwent similar platelet function testing.
연구 개요
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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District of Columbia
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Washington, District of Columbia, 미국, 20010
- MedStar Washington Hospital Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
Thirty African American patients with documented acute coronary syndrome who agree to participate in this clinical study and who sign an informed consent will be enrolled.
Race determination will be based on a patient's self-report, but patients enrolled in the trial must also report that all four of their grandparents were of the same race as theirs. Other races (Asian, Native American, etc) will be excluded from this study.
설명
Inclusion Criteria:
- Female (post menopausal or surgically sterile) and/or male aged 18 years or older
Presenting with ACS fulfilling the following:
- Symptoms or new ECG changes (ST segment elevation or depression of at least 1 mm in 2 or more contiguous leads on EKG)
- Elevation of biomarkers (CK-MB ≥2 ULN or troponin ≥ ULN)
- Self-identified as African-American
- Treatment with 75-100mg ASA daily
Exclusion Criteria:
- Any indication (atrial fibrillation, mitral stenosis or prosthetic heart valve, PE, DVT) for antithrombotic treatment during study period.
- Fibrinolytic therapy within 48 hours before randomization
- Concomitant therapy with a drug having possible interaction with ticagrelor. (concomitant therapy with a strong cytochrome P-450 3A inhibitor or inducer)
- Increased bleeding risk including: recent (<30 days) GI bleeding, any history of intracranial, intraocular, retroperitoneal, or spinal bleeding, recent (<30 days of dosing) major trauma, sustained uncontrolled hypertension (systolic blood pressure [SBP]>180mmHg or diastolic blood pressure [DBP]>100mmHg), history of hemorrhagic disorders that can increase the risk of bleeding, platelet count less than 100,000 mm3 or hemoglobin <10 g/dL.
- Any history of hemorrhagic stroke.
- Contraindication or other reason that ASA or ticagrelor should not be administered (e.g., hypersensitivity, active bleeding, major surgery within 30 days of dosing).
- Severe renal failure (creatinine clearance <30mL/min or patient requires dialysis)
- History of moderate or severe hepatic impairment with aspartate amino transferace, alanine amino transferase or total bilirubin > 1.5 x upper limit of the reference range.
- Pregnant or lactating women.
- Patients receiving any glycoprotein IIb/IIIa inhibitors <8 hours before platelet reactivity testing.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
---|---|
AA Ticagrelor
African Americans who present with acute coronary syndrome (ACS) to the cath lab, and receive ticagrelor during their hospital stay.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Ticagrelor Inhibition
기간: 1-2 days
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The primary objective of the study is to assess ticagrelor's inhibition of platelet activity using 3 assays simultaneously: VerifyNow P2Y12 (PRU), vasodilator-stimulated phosphoprotein phosphorylation (VASP) and light transmission aggregometry (LTA) in African-American patients presenting with ACS.
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1-2 days
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Follow-up Adverse Events
기간: 30 days
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To evaluate the safety of ticagrelor treatment in African-American patients by assessment of adverse-events up to 30-day follow-up time point.
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30 days
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공동 작업자 및 조사자
수사관
- 수석 연구원: Ron Waksman, MD, MedStar Washington Hospital Center
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- ACS Brilinta AZ
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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