Status:
COMPLETED
Modified-release Dipyridamole/Aspirin (200mg/25mg bd) Versus Aspirin (75mg) in Aspirin-resistant Patients
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Coronary Arteriosclerosis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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, platele...
Eligibility Criteria
Inclusion
- Cardiovascular disease (including history of stroke or transient ischaemic attack)
- Documented evidence of resistance to aspirin
- Capable of comprehending and communicating effectively with the investigator and staff and of providing informed consent.
- Willing to give informed consent prior to participation in the trial.
Exclusion
- Any clinically significant condition other than cardiovascular disease.
- Clinically significant abnormal baseline haematology, blood chemistry or urinalysis findings.
- Use of dipyridamole, clopidogrel, ticlopidine or any non-steroidal anti-inflammatory agent (NSAID)(including COX-2 inhibitors) during the two weeks before randomisation and during the trial.
- Active peptic ulceration or history of peptic ulcer disease.
- Known history of or suspected hypersensitivity to dipyridamole, aspirin, any NSAID or any other component of the test drugs.
- History of any bleeding disorder.
- History of cerebral haemorrhage.
- Resting seated blood pressure less than 90/60mmHg.
- Participation in any drug clinical trial within sixteen weeks prior to the start of the trial.
- Any indication of current or previous abuse of alcohol, solvents or drugs.
- Asthma.
- Pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception (e.g. oral contraceptives, intrauterine devices or surgically sterile).
- Previous participation in the randomisation phase of this clinical trial.
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT00129038
Start Date
April 1 2004
Last Update
January 23 2025
Active Locations (2)
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1
9.169.01 Dept of Clinical Pharmacology
Dublin, Ireland
2
9.169.02 St. James' Hospital
Dublin, Ireland