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

NCT00906035 | Terminated Results

• 2 other identifiers: 7064690821
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Peripheral Arterial Disease

Keywords

Peripheral Arterial Disease; PAD; Claudication; Peripheral Vascular Disease

Outcome Measures

Primary Outcomes (1)

• 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.

  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

Secondary Outcomes (2)

• 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.

  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.

  Predose and dosing days 30, 90 and 180.

Study Arms (3)

Dipyridamole 200mg and Aspirin 25mg bid

ACTIVE COMPARATOR

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.

Drug: Dipyridamole 200mg and Aspirin 25mg bid:

Dipyridamole 200 mg bid

ACTIVE COMPARATOR

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.

Drug: Dipyridamole 200 mg bid

Aspirin 25 mg bid

ACTIVE COMPARATOR

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.

Drug: Aspirin 25 mg bid

Interventions

Dipyridamole 200mg and Aspirin 25mg bid: DRUG

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.

Also known as: Persantine

Dipyridamole 200mg and Aspirin 25mg bid

Dipyridamole 200 mg bid DRUG

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.

Also known as: Persantine

Dipyridamole 200 mg bid

Aspirin 25 mg bid DRUG

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.

Aspirin 25 mg bid

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pennsylvania: lead
• Boehringer Ingelheim: collaborator

Study Sites (3)

Presbyterian Hospital, 51 N. 39th St.

Philadelphia, Pennsylvania, 19104, United States

Location

Translational Research Ctr.,3400 Civic Center Blvd, Building 421, 10th floor, Room 421

Philadelphia, Pennsylvania, 19104, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Peripheral Arterial Disease; Intermittent Claudication; Peripheral Vascular Diseases

Interventions

Dipyridamole; Aspirin; BID protein, human

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Limitations and Caveats

Study encountered difficulty while attempting to find subjects who met all inclusion/exclusion criteria."0" indicated because no analysis was done on samples obtained. Data could not be analyzed due to insufficient number of participants enrolled.

Results Point of Contact

• Title: Emile Mohler, MD
• Organization: Upenn

Emile.Mohler@uphs.upenn.edu

215-573-6606

Study Officials

• Garret A FitzGerald, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• Emile R Mohler, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• Tilo Grosser, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2009
• First Posted: May 21, 2009
• Study Start: September 1, 2002
• Primary Completion: March 1, 2010
• Study Completion: April 1, 2010
• Last Updated: September 5, 2017
• Results First Posted: September 5, 2017

Record last verified: 2017-08

Locations

US (3)