Modified-Release Dipyridamole/Aspirin (200mg/25mg bd) Versus Aspirin (75mg) in Aspirin-Resistant Patients
Information source: Boehringer Ingelheim Pharmaceuticals
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Coronary Arteriosclerosis
Intervention: modified-release dipyridamole/aspirin (Drug); aspirin (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Boehringer Ingelheim Pharmaceuticals Official(s) and/or principal investigator(s):
Boehringer Ingelheim Study Coordinator, Study Chair, Affiliation: BIL UK / Ireland
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, platelet aggregation) in patients with cardiovascular disease who are known to be
resistant to aspirin alone.
Clinical Details
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.
Study design: Treatment, Randomized, Double-Blind, Active Control, Crossover Assignment, Pharmacodynamics Study
Primary outcome: The primary endpoint will be the proportion of patients classified as aspirin-resistant at the end of each treatment period (i.e. day 30)
Secondary outcome: Serum thromboxane B2, platelet aggregation (after epinephrine, ADP or collagen), plasma CD40L, markers of platelet activation, urine prostaglandins, bleeding time, blood prostaglandins and markers of blood coagulation
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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 NSA ID 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.
Locations and Contacts
Dept of Clinical Pharmacology, Dublin 9, Ireland
The James Connolly Memorial Hospital, Dublin 8, Ireland
Additional Information
Ending date: January 2007
Last updated: May 9, 2008
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