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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00129038
Recruitment Status : Completed
First Posted : August 11, 2005
Last Update Posted : October 29, 2013
Information provided by:
Boehringer Ingelheim

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

Condition or disease Intervention/treatment Phase
Coronary Arteriosclerosis Drug: modified-release dipyridamole/aspirin Drug: aspirin Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Primary Purpose: Treatment
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 Start Date : April 2004
Actual Primary Completion Date : January 2007

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. platelet aggregation in response to arachidonic acid [ Time Frame: baseline, day 14, day 30 of each period ]

Secondary Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00129038

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9.169.02 St. James' Hospital
Dublin 8, Ireland
9.169.01 Dept of Clinical Pharmacology
Dublin 9, Ireland
Sponsors and Collaborators
Boehringer Ingelheim
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Additional Information:
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Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim Identifier: NCT00129038    
Other Study ID Numbers: 9.169
First Posted: August 11, 2005    Key Record Dates
Last Update Posted: October 29, 2013
Last Verified: October 2013
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Coronary Disease
Heart Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Phosphodiesterase Inhibitors
Vasodilator Agents