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To compare the combination of acetylsalicylic acid (25 mg) + modified-release dipyridamole (200 mg) bd versus acetylsalicylic acid (75 mg dispersible tablet once daily) in its effect on inhibition of thromboxane B2 formation
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acetylsalicylic acid low dose with Asasantin® | Experimental |
| |
| Acetylsalicylic acid high dose | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Asasantin® | Drug |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute serum thromboxane B2 level | At day 3 after start of drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| Change in platelet aggregation | measured ex-vivo | At day 3 after start of drug administration |
| Change in time course of inhibition of serum thromboxane B2 | Pre-dose, up to day 14 after start of drug administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Acetylsalicylic acid low dose |
| Drug |
|
| Acetylsalicylic acid high dose | Drug |
|
| Change in time course of inhibition of platelet aggregation | Pre-dose, up to day 14 after start of drug administration |
| Changes from baseline in vital signs | systolic and diastolic blood pressure, pulse rate | Pre-dose, up to 14 days after first drug administration |
| Changes from baseline in laboratory tests | Pre-dose, up to 14 days after first drug administration |
| Changes from baseline in physical examination | Pre-dose, up to 14 days after first drug administration |
| Changes from baseline in 12-lead ECG | Pre-dose, up to 14 days after first drug administration |
| Number of patients with adverse events | Up to 14 days after start of drug administration |
| ID | Term |
|---|---|
| D000068342 | Aspirin, Dipyridamole Drug Combination |
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004176 | Dipyridamole |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
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