Modified-release Dipyridamole/Aspirin (200mg/25mg bd) Versus Aspirin (75mg) in Aspirin-resistant Patients

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 Overview

• Status: Completed
• Conditions: Coronary Arteriosclerosis
• Intervention / Treatment: Drug: aspirin; Drug: modified-release dipyridamole/aspirin

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Phase 4

Contacts and Locations

Study Locations

• Ireland
  • Dublin 8, Ireland
    • 9.169.02 St. James' Hospital
  • Dublin 9, Ireland
    • 9.169.01 Dept of Clinical Pharmacology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
platelet aggregation in response to arachidonic acid	baseline, day 14, day 30 of each period

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: April 1, 2004
• Primary Completion (Actual): January 1, 2007

Study Registration Dates

• First Submitted: August 10, 2005
• First Submitted That Met QC Criteria: August 10, 2005
• First Posted (Estimate): August 11, 2005

Study Record Updates

• Last Update Posted (Estimate): October 29, 2013
• Last Update Submitted That Met QC Criteria: October 28, 2013
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia; Arteriosclerosis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Phosphodiesterase Inhibitors; Aspirin; Dipyridamole; Aspirin, Dipyridamole Drug Combination
• Other Study ID Numbers: 9.169