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

2 agosto 2017 aggiornato da: 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.

Panoramica dello studio

Stato

Terminato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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).

Tipo di studio

Interventistico

Iscrizione (Effettivo)

25

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 79 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Triplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: 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.
Droga: 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.
Altri nomi:
  • Persantino
Comparatore attivo: 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.
Droga: 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.
Altri nomi:
  • Persantino
Comparatore attivo: 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.
Droga: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
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.
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
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.
Lasso di tempo: 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.
Lasso di tempo: 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.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of Pennsylvania

Collaboratori

Boehringer Ingelheim

Investigatori

  • Investigatore principale: Garret A FitzGerald, MD, University of Pennsylvania
  • Investigatore principale: Emile R Mohler, MD, University of Pennsylvania

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 settembre 2002

Completamento primario (Effettivo)

1 marzo 2010

Completamento dello studio (Effettivo)

1 aprile 2010

Date di iscrizione allo studio

Primo inviato

20 maggio 2009

Primo inviato che soddisfa i criteri di controllo qualità

20 maggio 2009

Primo Inserito (Stima)

21 maggio 2009

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

5 settembre 2017

Ultimo aggiornamento inviato che soddisfa i criteri QC

2 agosto 2017

Ultimo verificato

1 agosto 2017

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 706469
  • 0821

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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