Thalidomide fOr the Prevention of Restenosis After Coronary ArtERy Stent Implantation (TOP RACER)
Thalidomide fOr the Prevention of Restenosis After Coronary ArtERy Stent Implantation - The TOP RACER Trial
Percutaneous coronary intervention (PCI) with the use of bare metal stents is associated with restenosis in approximately 10% to 50% of cases.
Stenting may induce endothelial damage/dysfunction and inflammatory reactions, which in turn delay healing and endothelialization and may lead to restenosis and atherosclerosis within the stented segments.
The sedative and antinausea drug thalidomide has been shown to have both anti-inflammatory and antioncogenic properties that could be of benefit in case of PCI with stenting.
연구 개요
상세 설명
Percutaneous coronary intervention (PCI) with the use of bare metal stents is associated with restenosis in approximately 10% to 50% of cases.
Stenting may induce endothelial damage/dysfunction and inflammatory reactions, which in turn delay healing and endothelialization and may lead to restenosis and atherosclerosis within the stented segments.
Indeed, experimental studies indicate a marked activation of inflammatory cells at the site of stent struts, which is likely to play a key role in the process of neointimal proliferation and restenosis. Indeed, tumor necrosis factor and interleukins 1 and 6 are powerful stimuli for smooth muscle cell proliferation.
The sedative and antinausea drug thalidomide has been shown to have both anti-inflammatory and antioncogenic properties that could be of benefit in case of PCI with stenting.
The primary objective of this study is to carry out a double-blind, randomized, placebo-controlled study to assess the effects of oral thalidomide on restenosis rate after successful stent implantation.
연구 유형
등록 (예상)
단계
- 4단계
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- A de novo native coronary artery lesions (reference vessel diameter:2.5-3.75 mm)
- Class I indication to elective percutaneous coronary intervention
- Stable conditions and no recent acute coronary syndromes
- Normal baseline values of markers of myocardial damage (creatine kinase, creatine kinase-MB, myoglobin, and troponin I)
- Able to understand and willing to sign the informed CF
- Contraindications to DES Use (Clinical history difficult to obtain, Expected poor compliance with DAPT, Non-elective surgery required, Increased risk of bleeding
- Allergy to ASA or clopidogrel/prasugrel/ticagrelor, Indication for long-term anticoagulation, Large Vessels, Focal Lesions)
Exclusion Criteria:
- Women of child bearing potential patients must demonstrate a negative pregnancy test performed within 24 hours before CT
- Indications to DES Use (Small Vessels, Long Lesions Diabetes, In-Stent Restenosis, Complex lesions)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
위약 비교기: 위약
|
위약, 알약, p.d., 6주
|
|
활성 비교기: 탈리도마이드
|
탈리도마이드, 알약, 50mg, p.d., 6주
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Occurrence of binary restenosis 6 months after PCI
기간: 6 months
|
6-month angiographic evidence of binary restenosis (defined as an in-stent stenosis _50% at follow-up coronary angiography)
|
6 months
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Major adverse cardiac events 6 months after PCI
기간: 6 months
|
6-month incidence of major adverse cardiac events (MACE-death, myocardial infarction, target vessel revascularization)
|
6 months
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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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