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Completed

NCT Number: NCT00129038

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

9.169.01 Dept of Clinical Pharmacology, Dublin, Ireland

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

modified-release dipyridamole/aspirin

Drug

Aspirin

Drug

Primary outcomes

  1. platelet aggregation in response to arachidonic acid

    Time frame: baseline, day 14, day 30 of each period

Secondary outcomes

  1. platelet aggregation in response to epinephrine, adenosine diphosphate (ADP) and collagen

    Time frame: baseline, day 14, day 30 of each period

  2. serum thromboxane B2

    Time frame: baseline, day 14, day 30 of each period

  3. urinary 2,3,-dinor-6-keto-prostaglandin F1α

    Time frame: baseline, day 30 of each period

  4. urinary 11-dehydro-thromboxane B2

    Time frame: baseline, day 30 of each period

  5. plasma CD40L

    Time frame: baseline, day 14, day 30 of each period

  6. flow cytometry measurements of platelet receptors in blood samples

    Time frame: baseline, day 14, day 30 of each period

  7. bleeding time

    Time frame: day 30 of each period

  8. 6-keto-prostaglandin F1α (in bleeding time samples)

    Time frame: day 30 of each period

  9. thromboxane B2 (in bleeding time samples)

    Time frame: day 30 of each period

  10. flow cytometry measurements from bleeding time samples

    Time frame: day 30 of each period]

  11. coagulation markers F1.2 and fibrinopeptide A (in bleeding time samples)

    Time frame: day 30 of each period

  12. pulse rate and blood pressure

    Time frame: baseline, day 14, day 30 of each period

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study 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.

Important dates

Study start
2004
Primary completion
2007
First posted
Aug 11, 2005
Registry last updated
Jan 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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