Official Title: “A Randomised, Crossover Study Comparing the Biochemical and Platelet Effects of Modified-Release Dipyridamole/Aspirin (200mg/25 mg bd; Asasantin Retard®) With Aspirin (75 mg qd) in Coronary Artery Disease Patients With Aspirin Resistance Manifesting as Persistent Thromboxane Formation.”

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

Study Type: Interventional

Study Design: Treatment

Study Primary Completion Date: January 2007

Intervention(s) in this Clinical Trial

• Drug: modified-release dipyridamole/aspirin
• Drug: aspirin

Inclusion Criteria:

• 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 Criteria:

• 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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Boehringer Ingelheim Pharmaceuticals

Overall Clinical Trial Officials and Contacts

Boehringer Ingelheim Study Chair Boehringer Ingelheim Pharmaceuticals  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00129038

Study ID Number: 9.169

ClinicalTrials.gov Identifier: NCT00129038

Health Authority: Ireland: Irish Medicines Board