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| ID | Type | Description | Link |
|---|---|---|---|
| 0821 |
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Could not enroll subjects who met the stringent inclusion/exclusion criteria.
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| Name | Class |
|---|---|
| Boehringer Ingelheim | INDUSTRY |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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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:
Smokers who smoke < 10 cigarettes / day
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Presbyterian Hospital, 51 N. 39th St. | Philadelphia | Pennsylvania | 19104 | United States | ||
| Translational Research Ctr.,3400 Civic Center Blvd, Building 421, 10th floor, Room 421 |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 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. |
| FG001 | 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. 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. |
| FG002 | 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. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Data could not collected due to study termination related to the difficulty finding participants that matched the inclusion/exclusion criteria. Data could not be analyzed due to insufficient number of participants enrolled. | Posted | Predose and dosing days 30, 90 and 180 |
|
5 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac catherization of the pelvis | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| intermittent claudication | Vascular disorders | Systematic Assessment |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Emile Mohler, MD | Upenn | 215-573-6606 | Emile.Mohler@uphs.upenn.edu |
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| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| D007383 | Intermittent Claudication |
| D016491 | Peripheral Vascular Diseases |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D004176 | Dipyridamole |
| D001241 | Aspirin |
| C494814 | BID protein, human |
| ID | Term |
|---|---|
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D012459 | Salicylates |
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|
| 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. |
|
|
| 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. |
|
| 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. | Predose and dosing days 30, 90 and 180. |
| Philadelphia |
| Pennsylvania |
| 19104 |
| United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| BG001 | 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. 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. |
| BG002 | 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. 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. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 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. 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. |
| OG002 | 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. 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. |
|
| Secondary | 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. | 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. | Posted | Predose and dosing days 30, 90 and 180. |
|
|
| Secondary | 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. | 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. | Posted | Predose and dosing days 30, 90 and 180. |
|
|
| 2 |
| 8 |
| 5 |
| 8 |
| EG001 | 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. 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. | 1 | 9 | 4 | 9 |
| EG002 | 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. 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. | 1 | 8 | 5 | 8 |
| Chest pain | Cardiac disorders | Systematic Assessment |
|
| Surgical removal of renal tumor | Surgical and medical procedures | Systematic Assessment |
|
| balloon angioplasty left leg | Surgical and medical procedures | Systematic Assessment |
|
| Angina | Cardiac disorders | Systematic Assessment |
|
| Diarrhea | General disorders | Non-systematic Assessment |
|
| Headache | General disorders | Non-systematic Assessment |
|
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| D002318 |
| Cardiovascular Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D062385 |
| Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |