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The primary objective of this study is to assess whether adding modified-release dipyridamole to aspirin (Asasantin Retard) has measurable effects on markers of platelet function (for example, platelet aggregation) in patients with cardiovascular disease who are known to be resistant to aspirin alone
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| modified-release dipyridamole/aspirin | Drug | |||
| aspirin | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| platelet aggregation in response to arachidonic acid | baseline, day 14, day 30 of each period |
| Measure | Description | Time Frame |
|---|---|---|
| platelet aggregation in response to epinephrine, adenosine diphosphate (ADP) and collagen | baseline, day 14, day 30 of each period | |
| serum thromboxane B2 | baseline, day 14, day 30 of each period | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 9.169.01 Dept of Clinical Pharmacology | Dublin | Ireland | ||||
| 9.169.02 St. James' Hospital |
Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).
For more details refer to: https://www.mystudywindow.com/msw/datatransparency
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
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| urinary 2,3,-dinor-6-keto-prostaglandin F1α |
| baseline, day 30 of each period |
| urinary 11-dehydro-thromboxane B2 | baseline, day 30 of each period |
| plasma CD40L | baseline, day 14, day 30 of each period |
| flow cytometry measurements of platelet receptors in blood samples | baseline, day 14, day 30 of each period |
| bleeding time | day 30 of each period |
| 6-keto-prostaglandin F1α (in bleeding time samples) | day 30 of each period |
| thromboxane B2 (in bleeding time samples) | day 30 of each period |
| flow cytometry measurements from bleeding time samples | day 30 of each period] |
| coagulation markers F1.2 and fibrinopeptide A (in bleeding time samples) | day 30 of each period |
| pulse rate and blood pressure | baseline, day 14, day 30 of each period |
| Dublin |
| Ireland |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |