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

NCT00129038 | Completed Phase 4

• 1 other identifier: 9.169
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 2

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, platelet aggregation) in patients with cardiovascular disease who are known to be resistant to aspirin alone

Conditions

Coronary Arteriosclerosis

Outcome Measures

Primary Outcomes (1)

• platelet aggregation in response to arachidonic acid

  baseline, day 14, day 30 of each period

Secondary Outcomes (12)

• 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

Interventions

modified-release dipyridamole/aspirin DRUG

aspirin DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (2)

9.169.01 Dept of Clinical Pharmacology

Dublin, Ireland

Location

9.169.02 St. James' Hospital

Dublin, Ireland

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2005
• First Posted: August 11, 2005
• Study Start: April 1, 2004
• Primary Completion: January 1, 2007
• Last Updated: January 23, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

IE (2)