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

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00129038
First received: August 10, 2005
Last updated: October 28, 2013
Last verified: October 2013
  Purpose

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 Intervention Phase
Coronary Arteriosclerosis
Drug: modified-release dipyridamole/aspirin
Drug: aspirin
Phase 4

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • platelet aggregation in response to arachidonic acid [ Time Frame: baseline, day 14, day 30 of each period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • platelet aggregation in response to epinephrine, adenosine diphosphate (ADP) and collagen [ Time Frame: baseline, day 14, day 30 of each period ] [ Designated as safety issue: No ]
  • serum thromboxane B2 [ Time Frame: baseline, day 14, day 30 of each period ] [ Designated as safety issue: No ]
  • urinary 2,3,-dinor-6-keto-prostaglandin F1α [ Time Frame: baseline, day 30 of each period ] [ Designated as safety issue: No ]
  • urinary 11-dehydro-thromboxane B2 [ Time Frame: baseline, day 30 of each period ] [ Designated as safety issue: No ]
  • plasma CD40L [ Time Frame: baseline, day 14, day 30 of each period ] [ Designated as safety issue: No ]
  • flow cytometry measurements of platelet receptors in blood samples [ Time Frame: baseline, day 14, day 30 of each period ] [ Designated as safety issue: No ]
  • bleeding time [ Time Frame: day 30 of each period ] [ Designated as safety issue: No ]
  • 6-keto-prostaglandin F1α (in bleeding time samples) [ Time Frame: day 30 of each period ] [ Designated as safety issue: No ]
  • thromboxane B2 (in bleeding time samples) [ Time Frame: day 30 of each period ] [ Designated as safety issue: No ]
  • flow cytometry measurements from bleeding time samples [ Time Frame: day 30 of each period] ] [ Designated as safety issue: No ]
  • coagulation markers F1.2 and fibrinopeptide A (in bleeding time samples) [ Time Frame: day 30 of each period ] [ Designated as safety issue: No ]
  • pulse rate and blood pressure [ Time Frame: baseline, day 14, day 30 of each period ] [ Designated as safety issue: No ]

Enrollment: 11
Study Start Date: April 2004
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00129038

Locations
Ireland
9.169.02 St. James' Hospital
Dublin 8, Ireland
9.169.01 Dept of Clinical Pharmacology
Dublin 9, Ireland
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
No publications provided

Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00129038     History of Changes
Other Study ID Numbers: 9.169
Study First Received: August 10, 2005
Last Updated: October 28, 2013
Health Authority: Ireland: Irish Medicines Board

Additional relevant MeSH terms:
Arteriosclerosis
Coronary Artery Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Coronary Disease
Heart Diseases
Aspirin
Dipyridamole
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 22, 2014