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- Essai clinique NCT00906035
The Vascular Biology of Dipyridamole in Peripheral Arterial Disease (PAD)
2 août 2017 mis à jour par: 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.
Aperçu de l'étude
Statut
Résilié
Les conditions
Description détaillée
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).
Type d'étude
Interventionnel
Inscription (Réel)
25
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Pennsylvania
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Philadelphia, Pennsylvania, États-Unis, 19104
- University of Pennsylvania
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Philadelphia, Pennsylvania, États-Unis, 19104
- Presbyterian Hospital, 51 N. 39th St.
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Philadelphia, Pennsylvania, États-Unis, 19104
- Translational Research Ctr.,3400 Civic Center Blvd, Building 421, 10th floor, Room 421
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans à 79 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Comparateur actif: 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.
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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.
Autres noms:
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Comparateur actif: 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.
Autres noms:
|
Comparateur actif: 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.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
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.
Délai: Predose and dosing days 30, 90 and 180
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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.
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Predose and dosing days 30, 90 and 180
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
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.
Délai: Predose and dosing days 30, 90 and 180.
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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.
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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.
Délai: Predose and dosing days 30, 90 and 180.
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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.
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Predose and dosing days 30, 90 and 180.
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Garret A FitzGerald, MD, University of Pennsylvania
- Chercheur principal: Emile R Mohler, MD, University of Pennsylvania
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 septembre 2002
Achèvement primaire (Réel)
1 mars 2010
Achèvement de l'étude (Réel)
1 avril 2010
Dates d'inscription aux études
Première soumission
20 mai 2009
Première soumission répondant aux critères de contrôle qualité
20 mai 2009
Première publication (Estimation)
21 mai 2009
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
5 septembre 2017
Dernière mise à jour soumise répondant aux critères de contrôle qualité
2 août 2017
Dernière vérification
1 août 2017
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Maladies cardiovasculaires
- Maladies vasculaires
- Artériosclérose
- Maladies artérielles occlusives
- Athérosclérose
- Maladie artérielle périphérique
- Maladies vasculaires périphériques
- Effets physiologiques des médicaments
- Mécanismes moléculaires de l'action pharmacologique
- Agents vasodilatateurs
- Agents du système nerveux périphérique
- Inhibiteurs d'enzymes
- Analgésiques
- Agents du système sensoriel
- Agents anti-inflammatoires non stéroïdiens
- Analgésiques, non narcotiques
- Agents anti-inflammatoires
- Agents antirhumatismaux
- Agents fibrinolytiques
- Agents modulateurs de fibrine
- Inhibiteurs de l'agrégation plaquettaire
- Inhibiteurs de la cyclooxygénase
- Antipyrétiques
- Inhibiteurs de la phosphodiestérase
- Aspirine
- Dipyridamole
Autres numéros d'identification d'étude
- 706469
- 0821
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
Essais cliniques sur Maladie artérielle périphérique
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Mayo ClinicInscription sur invitationAnatomie du GSV pour Rescue Peripheral IV AccessÉtats-Unis
Essais cliniques sur Dipyridamole 200mg and Aspirin 25mg bid:
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Boehringer IngelheimComplétéAccident vasculaire cérébralAllemagne