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NIRS Ticagrelor Evaluation

2021년 3월 11일 업데이트: Medstar Health Research Institute

The Impact of Ticagrelor on Coronary Atherosclerotic Lipid Pool and Inflammation Assessed by Near-Infrared Spectroscopy

The Impact of Ticagrelor on Coronary Atherosclerotic Lipid Pool and Inflammation Assessed by Near-Infrared Spectroscopy study will evaluate whether ticagrelor leads to a 20% reduction in the LCBI with NIRS/IVUS suggesting coronary plaque stabilization and reduced inflammation in patients already on long-term statin therapy undergoing non-urgent PCI. It is hypothesized that the treatment with ticagrelor following PCI will lead to a significant 20% reduction in the lipid pool as measured by NIRS/IVUS at follow-up when compared with baseline imaging, suggesting a reduction in inflammation and stabilization of the lipid core in atherosclerotic lesions not treated during the index procedure.

연구 개요

상태

완전한

상세 설명

Single-Center, open-label study of the effect of ticagrelor on the reduction in the lipid pool in 30 patients with multi-vessel CAD 2 Treatment periods over 6 months, with 2 additional follow-up phone calls at 1 and 3 months.

Non-urgent PCI requiring stent placement and evaluation by NIRS/IVUS at baseline and 6 month follow up A second concomitant coronary lesion with diameter stenosis greater than 50% will also be imaged using NIRS/IVUS.

Patients will be discharged on a ticagrelor regiment of 90 mg twice a day for the 6 month study.

Blood samples will be drawn at baseline prior to ticagrelor being administered and again at follow up.

Inclusion Criteria:

  • Female (post menopausal or surgically sterile) and/or male aged 18 years or older
  • Multi-vessel coronary artery disease
  • Statin therapy for minimum of 6 weeks prior to enrollment in the study with no plan for further adjustment
  • Non-emergent PCI for ACS with stent placement requiring dual-antiplatelet therapy
  • Ability to safely perform NIRS/IVUS for a concomitant non-culprit lesion with diameter stenosis ≥ 50% that was not treated with PCI
  • Willing and able to sign informed consent and participate in follow-up

Exclusion Criteria:

  • Thienopyridine or ticagrelor use in the last month
  • Need for coronary artery bypass surgery or other surgeries during the follow-up period
  • Documented medication non-compliance
  • Chronic inflammatory disorder or treatment with anti-inflammatory or immunosuppressive drugs
  • Prior or current malignancy within the last 5 years
  • Concomitant severe illness or reduced life expectancy that will prevent follow-up cardiac catheterization
  • Active infection
  • Pregnant or lactating women
  • End-stage renal disease
  • History of intracranial hemorrhage
  • Active pathological bleeding
  • Known sever hepatic impairment
  • Known hypersensitivity to ticagrelor

Study Procedures:

After consent is obtained non-urgent PCI requiring stent placement and evaluation by NIRS/IVUS at baseline is performed and once again at 6 month follow up. A second concomitant coronary lesion with diameter stenosis greater than 50% will also be imaged using NIRS/IVUS. Patients will be discharged on a ticagrelor regiment of 90 mg twice a day for the 6 month study.Blood samples will be drawn at baseline prior to ticagrelor being administered and again at follow up. There will be 1 month phone follow up, 3 month phone follow up and a 6 month clinical follow up that includes collecting blood, repeat catheterization, and repeat NIRS/IVUS procedure.

연구 유형

중재적

등록 (실제)

30

단계

  • 4단계

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

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  • • Female (post menopausal or surgically sterile) and/or male aged 18 years or older

    • Multi-vessel coronary artery disease CAD
    • Statin therapy for minimum of 6 weeks prior to enrollment in the study with no plan for further adjustment
    • Non-emergent PCI for ACS with stent placement requiring dual-antiplatelet therapy
    • Ability to safely perform NIRS/IVUS for a concomitant non-culprit lesion with diameter stenosis ≥50% that was not treated with PCI
    • Willing and able to sign informed consent and participate in follow-up

Exclusion Criteria:

  • Thienopyridine or ticagrelor use in the last month
  • Need for coronary artery bypass surgery or other surgeries during the follow-up period
  • Documented medication non-compliance
  • Chronic inflammatory disorder or treatment with anti-inflammatory or immunosuppressive drugs
  • Prior or current malignancy within the last 5 years
  • Concomitant severe illness or reduced life expectancy that will prevent follow-up cardiac catheterization
  • Active infection
  • Pregnant or lactating women
  • End-stage renal disease
  • History of intracranial hemorrhage
  • Active pathological bleeding
  • Known severe hepatic impairment
  • Known hypersensitivity to ticagrelor

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 방지
  • 할당: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Patiens Discharged on Ticagrelor
Patients to be discharged on ticagrlore regiment of 90mg twice a day for 6 months.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change From Baseline Lipid Pool to Follow up as Assessed by NIRS/IVUS With Treatment of Ticagrelor
기간: 6 months
Treatment with ticagrelor following PCI will lead to significant 20% reduction in the LCBI as assessed at follow up by NIRS/IVUS when compared with baseline imaging data of the reference vessel, suggesting a reduction in inflammation and stabilization of the lipid core in atherosclerotic lesions not treated during the index procedure.
6 months

2차 결과 측정

결과 측정
측정값 설명
기간
Change From Baseline Inflammatory Markers to Follow up With Treatment of Ticagrelor
기간: 6 months
We expect to see a significant reduction of inflammatory markers of Hs-CRP, MCP-1, IL-1, IL-6, IL-18, and TNF- α as well as an increase in IL-10, a cytokine associated with a reduction in inflammation, following therapy with ticagrelor when compared with baseline values. This is expected as inflammatory markers should be lower in stable coronary artery disease compared with patients presenting with ACS. While there is no control group in the proposed study, it will be important to assess whether changes in established biomarkers associated with inflammation correlate with changes in LCBI. While ticagrelor was not shown to reduce inflammatory biomarkers to a greater degree than clopidogrel, it will be important to assess whether the reduction in LCBI is independent of or associated with reductions in inflammatory markers or platelet reactivity.
6 months

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

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

2014년 6월 1일

기본 완료 (실제)

2016년 4월 1일

연구 완료 (실제)

2016년 4월 1일

연구 등록 날짜

최초 제출

2014년 10월 15일

QC 기준을 충족하는 최초 제출

2014년 10월 31일

처음 게시됨 (추정)

2014년 11월 4일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2021년 4월 8일

QC 기준을 충족하는 마지막 업데이트 제출

2021년 3월 11일

마지막으로 확인됨

2021년 3월 1일

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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