Peripheral Arterial DiseaseNCT00906035
The Vascular Biology of Dipyridamole in Peripheral Arterial Disease (PAD)
A study testing Dipyridamole 200mg and Aspirin 25mg bid:, Dipyridamole 200 mg bid and Aspirin 25 mg bid in people with Peripheral Arterial Disease, run by University of Pennsylvania at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Dipyridamole 200mg and Aspirin 25mg bid:, Dipyridamole 200 mg bid and Aspirin 25 mg bid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 3 sitesUnited States
- Study dates
- Sep 2002to Apr 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 23Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Presbyterian Hospital, 51 N. 39th St.
Philadelphia, Pennsylvania, 19104
Translational Research Ctr.,3400 Civic Center Blvd, Building 421, 10th floor, Room 421
Philadelphia, Pennsylvania, 19104
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
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.
Read the detailed description
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).
- Conditions
- Peripheral Arterial Disease
- Being tested
- Dipyridamole 200mg and Aspirin 25mg bid:, Dipyridamole 200 mg bid, Aspirin 25 mg bid
- Keywords
- Peripheral Arterial Disease, PAD, Claudication, Peripheral Vascular Disease
- Medical subject headings
- Peripheral Arterial Disease, Intermittent Claudication, Peripheral Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dipyridamole 200mg and Aspirin 25mg bid:Drug
Also called Persantine
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.
Dipyridamole 200 mg bidDrug
Also called Persantine
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 bidDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Drug: Aspirin 25 mg bid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: Predose and dosing days 30, 90 and 180.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2009 (estimated)
- Study startSep 2002
- Primary completionMar 2010
- Study completionApr 2010
Why it stopped: Could not enroll subjects who met the stringent inclusion/exclusion criteria.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Boehringer Ingelheim
- Responsible party
- Sponsor
- Investigators
- Garret A FitzGerald, MD, Principal investigator, University of PennsylvaniaEmile R Mohler, MD, Principal investigator, University of PennsylvaniaTilo Grosser, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00906035
- Sponsor's protocol ID
- 706469
- Other IDs
- 0821
- Status last verified
- Aug 2017
- First submitted
- 20 May 2009
- Last updated
- 5 Sep 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Vascular Biology of Dipyridamole in Peripheral Arterial Disease (PAD)
- ClinicalTrials.gov ID
- NCT00906035
- Acronym / sponsor ID
- 706469
- Conditions
- Peripheral Arterial Disease
- Keywords
- Peripheral Arterial Disease, PAD, Claudication, Peripheral Vascular Disease
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Could not enroll subjects who met the stringent inclusion/exclusion criteria.
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Boehringer Ingelheim
- Study start
- Sep 2002
- Primary completion
- Mar 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 21 May 2009 (estimated)
- Results
- Posted 5 Sep 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dipyridamole 200mg and Aspirin 25mg bid | Active comparator | Drug: 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. |
| Dipyridamole 200 mg bid | Active comparator | Drug: Dipyridamole 200 mg bidAll 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. |
| Aspirin 25 mg bid | Active comparator | Drug: Aspirin 25 mg bidAll 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. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
- Smokers who smoke < 10 cigarettes / day
Key exclusion criteria (23 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dipyridamole 200mg and Aspirin 25mg bid:Also: PersantineAll 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. | Drug | Dipyridamole 200mg and Aspirin 25mg bid |
| Dipyridamole 200 mg bidAlso: PersantineAll 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. | Drug | Dipyridamole 200 mg bid |
| Aspirin 25 mg bidAll 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. | Drug | Aspirin 25 mg bid |
Primary outcome
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.
Time frame: 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.
2 secondary outcomes
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.
Time frame: 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.
Time frame: Predose and dosing days 30, 90 and 180.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Garret A FitzGerald, MD principal investigator
University of Pennsylvania
Emile R Mohler, MD principal investigator
University of Pennsylvania
Tilo Grosser, MD principal investigator
University of Pennsylvania
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dipyridamole 200mg and Aspirin 25mg bid:, Dipyridamole 200 mg bid and Aspirin 25 mg bid in people with Peripheral Arterial Disease, run by University of Pennsylvania at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Sep 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: Predose and dosing days 30, 90 and 180). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2017.