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Modified-Release Dipyridamole/Aspirin (200mg/25mg bd) Versus Aspirin (75mg) in Aspirin-Resistant Patients
This study has been completed.
First Received: August 10, 2005   Last Updated: April 24, 2009   History of Changes
Sponsored by: Boehringer Ingelheim Pharmaceuticals
Information provided by: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00129038
  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 IV

Study Type: Interventional
Study Design: 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 Pharmaceuticals:

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

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

No publications provided

Responsible Party: Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair )
Study ID Numbers: 9.169
Study First Received: August 10, 2005
Last Updated: April 24, 2009
ClinicalTrials.gov Identifier: NCT00129038     History of Changes
Health Authority: Ireland: Irish Medicines Board

Study placed in the following topic categories:
Arterial Occlusive Diseases
Anti-Inflammatory Agents
Vasodilator Agents
Heart Diseases
Myocardial Ischemia
Cyclooxygenase Inhibitors
Vascular Diseases
Fibrinolytic Agents
Cardiovascular Agents
Arteriosclerosis
Ischemia
Coronary Disease
Fibrin Modulating Agents
Phosphodiesterase Inhibitors
Aspirin
Analgesics, Non-Narcotic
Platelet Aggregation Inhibitors
Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents
Dipyridamole
Coronary Artery Disease

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

ClinicalTrials.gov processed this record on July 02, 2009