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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

August 10, 2005
October 28, 2013
April 2004
January 2007   (final data collection date for primary outcome measure)
platelet aggregation in response to arachidonic acid [ Time Frame: baseline, day 14, day 30 of each period ] [ Designated as safety issue: No ]
The primary endpoint will be the proportion of patients classified as aspirin-resistant at the end of each treatment period (i.e. day 30)
Complete list of historical versions of study NCT00129038 on ClinicalTrials.gov Archive Site
  • 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 ]
Serum thromboxane B2, platelet aggregation (after epinephrine, ADP or collagen), plasma CD40L, markers of platelet activation, urine prostaglandins, bleeding time, blood prostaglandins and markers of blood coagulation
Not Provided
Not Provided
 
Modified-release Dipyridamole/Aspirin (200mg/25mg bd) Versus Aspirin (75mg) in Aspirin-resistant Patients
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.

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

Not Provided
Interventional
Phase 4
Primary Purpose: Treatment
Coronary Arteriosclerosis
  • Drug: modified-release dipyridamole/aspirin
  • Drug: aspirin
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
11
Not Provided
January 2007   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Ireland
 
NCT00129038
9.169
Not Provided
Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP