The Vascular Biology of Dipyridamole in Peripheral Arterial Disease (PAD)
2017年8月2日 更新者：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.
調査の概要
状態
終了しました
条件
詳細な説明
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).
研究の種類
介入
入学 (実際)
25
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Pennsylvania
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Philadelphia、Pennsylvania、アメリカ、19104
- University of Pennsylvania
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Philadelphia、Pennsylvania、アメリカ、19104
- Presbyterian Hospital, 51 N. 39th St.
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Philadelphia、Pennsylvania、アメリカ、19104
- Translational Research Ctr.,3400 Civic Center Blvd, Building 421, 10th floor, Room 421
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-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年～79年 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：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.
|
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.
他の名前：
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アクティブコンパレータ：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.
|
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.
他の名前：
|
|
アクティブコンパレータ：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.
|
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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
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.
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
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.
時間枠：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.
|
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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.
時間枠：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.
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Garret A FitzGerald, MD、University of Pennsylvania
- 主任研究者：Emile R Mohler, MD、University of Pennsylvania
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2002年9月1日
一次修了 (実際)
2010年3月1日
研究の完了 (実際)
2010年4月1日
試験登録日
最初に提出
2009年5月20日
QC基準を満たした最初の提出物
2009年5月20日
最初の投稿 (見積もり)
2009年5月21日
学習記録の更新
投稿された最後の更新 (実際)
2017年9月5日
QC基準を満たした最後の更新が送信されました
2017年8月2日
最終確認日
2017年8月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。