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The Vascular Biology of Dipyridamole in Peripheral Arterial Disease (PAD)

2017년 8월 2일 업데이트: University of Pennsylvania
This research study will evaluate the effects of aspirin and dipyridamole alone and in combination on the blood flow in the vessels of the legs. We will examine how these medications are able to inhibit the clotting of platelets in the vessels of patients with PAD, and thereby affect the blood flow in the legs. Platelets are cells in the blood that have the ability to adhere to each other to form clots.

연구 개요

상태

종료됨

정황

개입 / 치료

상세 설명

Dipyridamole has been reformulated to guarantee systemic bioavailability and steady state levels compatible with inhibition of platelet aggregation ex vivo (1). This newly formulated dipyridamole has been shown to roughly equal in efficacy to low dose aspirin in the secondary prevention of stroke and the drug combination seems roughly additive (2). The present study is designed to explore two potential mechanisms which have been linked to dipyridamole action on the vessel wall; modulation of vascular eicosanoid generation and prevention of oxidant stress (3). We shall address the hypothesis that dipyridamole affects these systems in patients with PAD. These individuals have disordered platelet-vascular interactions, as reflected by increased generation of thromboxane, an index of platelet activation and of prostacyclin, probably a homeostatic response to traumatic and chemical stimulation of the endothelium (4,5). Furthermore, we shall assess the functional consequences of dipyridamole action, alone and in combination with aspirin compared with aspirin alone on local measurements of flow and oxygenation, including exercise tolerance, Doppler Ultrasound and Near Infrared Spectroscopy (NIRS). Lipid peroxidation will be quantified based on mass spectrometric analysis of the major urinary isoprostane, 8,12-iso-iPF2a-VI (6,7).

연구 유형

중재적

등록 (실제)

25

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 미국
    • Pennsylvania
      • Philadelphia, Pennsylvania, 미국, 19104
        • University of Pennsylvania
      • Philadelphia, Pennsylvania, 미국, 19104
        • Presbyterian Hospital, 51 N. 39th St.
      • Philadelphia, Pennsylvania, 미국, 19104
        • Translational Research Ctr.,3400 Civic Center Blvd, Building 421, 10th floor, Room 421

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 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  • Age between 18 - 79
  • Women of child bearing potential using a medically acceptable method of birth control (oral/transdermal/vaginal hormonal contraception, depo-provera injection, IUD, condom with spermicide, progestin implant, tubal ligation, oophorectomy, TAH) or abstinence.
  • Capacity for giving written consent

  • Diagnosis of PAD by:

    • previous angiogram (>0.5 stenosis of a peripheral artery)
    • ankle-brachial index (ABI) of systolic pressure <0.80
    • previous peripheral revascularization
  • Smokers who smoke < 10 cigarettes / day

Exclusion Criteria:

  • Female subjects who are pregnant or nursing a child.
  • Prior bleeding event related to drug therapy
  • History of gastrointestinal ulceration
  • History of known dipyridamole and/or aspirin allergy or intolerance
  • History of coagulation, bleeding or blood disorders.
  • Recent history of myocardial infarction or stroke in the previous 6 months
  • Resting blood pressure of <110mmHg systolic or <60mmHg diastolic or of >165mmHg systolic or >95mmHg diastolic
  • Patients with active infection as documented by abnormal laboratory tests at screen
  • Concomitant serious illness, such as cancer, as per the principal investigator's discretion
  • Current use of steroids for a chronic disease process
  • Presence of ischemic leg ulcers
  • History of contact allergies to the metal leads of the NIRS
  • History of drug or alcohol abuse within the last 6 months.
  • Subject who has received an experimental drug and/or used an experimental device within 30 days of screening.
  • Subject who has donated ≥ one pint of blood within 8 weeks prior to screen.
  • Use of aspirin for 2 weeks prior to the study
  • Use of any other NSAID or COX-inhibitor for one week prior to the start of the study
  • Use of any antioxidant vitamin for 2 weeks prior to the start of the study
  • Use of plavix, pletal or trental for one week prior to the start of the study
  • Use of acetaminophen for one week prior to each study visit
  • Use of alcohol, caffeine or high fat foods for 24 hours prior to each study visit
  • Has smoked any cigarettes for 24 hours prior to each study visit
  • Platelet aggregation blood test less than 60 percent at Visit 1

공부 계획

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

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 삼루타

무기와 개입

참가자 그룹 / 팔
개입 / 치료
활성 비교기: Dipyridamole 200mg and Aspirin 25mg bid
All subjects in this arm will take their assigned medication for 180 days and complete study visits on Day 1(Baseline), 30, 90 and 180. All subjects will bring a 24 hour urine collection and arrive in a fasting state on all visit days for a blood draw after which they will receive breakfast. After assessing vitals, Adverse Event status and medication compliance, they will be escorted to the vascular labs for Doppler Ultrasound and Near Infrared Spectroscopy. (NIRS) of the legs.
의약품: Dipyridamole 200mg and Aspirin 25mg bid:
All subjects will receive their randomly assigned study medication to be taken each morning and evening approximately 8am and 8 pm for the 180 day duration of the study.
다른 이름들:
  • 페르산틴
활성 비교기: Dipyridamole 200 mg bid
All subjects in this arm will take their assigned medication for 180 days and complete study visits on Day 1(Baseline), 30, 90 and 180. All subjects will bring a 24 hour urine collection and arrive in a fasting state on all visit days for a blood draw after which they will receive breakfast. After assessing vitals, Adverse Event status and medication compliance, they will be escorted to the vascular labs for Doppler Ultrasound and Near Infrared Spectroscopy. (NIRS) of the legs.
의약품: Dipyridamole 200 mg bid
All subjects will receive their randomly assigned study medication to be taken each morning and evening approximately 8am and 8 pm for the 180 day duration of the study.
다른 이름들:
  • 페르산틴
활성 비교기: Aspirin 25 mg bid
All subjects in this arm will take their assigned medication for 180 days and complete study visits on Day 1(Baseline), 30, 90 and 180. All subjects will bring a 24 hour urine collection and arrive in a fasting state on all visit days for a blood draw after which they will receive breakfast. After assessing vitals, Adverse Event status and medication compliance, they will be escorted to the vascular labs for Doppler Ultrasound and Near Infrared Spectroscopy (NIRS) of the legs.
의약품: Aspirin 25 mg bid
All subjects will receive their randomly assigned study medication to be taken each morning and evening approximately 8am and 8 pm for the 180 day duration of the study.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
The Present Study is Designed to Explore Two Potential Mechanisms Which Have Been Linked to Dipyridamole Action on the Vessel Wall; Modulation of Vascular Eicosanoid Generation and Prevention of Oxidant Stress.
기간: Predose and dosing days 30, 90 and 180
No analysis could be performed due to the insufficent number of participants enrolled. Data were not collected due to study termination related to the difficulty finding participants that matched the inclusion/exclusion criteria.
Predose and dosing days 30, 90 and 180

2차 결과 측정

결과 측정
측정값 설명
기간
Assess the Functional Consequences of Dipyridamole Action, Alone and in Combination With Aspirin Compared With Aspirin Alone on Local Measurements of Flow and Oxygenation. Blood Flow Reporting to Added Table.
기간: Predose and dosing days 30, 90 and 180.
Done by doppler ultrasound. Data could not be analyzed due to insufficient number of participants enrolled. Data were not collected due to study termination related to the difficulty finding participants that matched the inclusion/exclusion criteria.
Predose and dosing days 30, 90 and 180.
Assess the Functional Consequences of Dipyridamole Action, Alone and in Combination With Aspirin Compared With Aspirin Alone on Local Measurements of Flow and Oxygenation. Reporting Blood Oxygenation.
기간: Predose and dosing days 30, 90 and 180.
Reporting blood oxygenation. Data could not be analyzed due to insufficient number of participants enrolled. Difficulty finding participants who fit into the inclusion/exclusion criteria.
Predose and dosing days 30, 90 and 180.

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

University of Pennsylvania

협력자

Boehringer Ingelheim

수사관

  • 수석 연구원: Garret A FitzGerald, MD, University of Pennsylvania
  • 수석 연구원: Emile R Mohler, MD, University of Pennsylvania

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

2002년 9월 1일

기본 완료 (실제)

2010년 3월 1일

연구 완료 (실제)

2010년 4월 1일

연구 등록 날짜

최초 제출

2009년 5월 20일

QC 기준을 충족하는 최초 제출

2009년 5월 20일

처음 게시됨 (추정)

2009년 5월 21일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2017년 9월 5일

QC 기준을 충족하는 마지막 업데이트 제출

2017년 8월 2일

마지막으로 확인됨

2017년 8월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 706469
  • 0821

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. .

말초 동맥 질환에 대한 임상 시험

Dipyridamole 200mg and Aspirin 25mg bid:에 대한 임상 시험

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스폰서 / 협력자

위치

3
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