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

Primary Purpose

Coronary Arteriosclerosis

Status
Completed
Phase
Phase 4
Locations
Ireland
Study Type
Interventional
Intervention
modified-release dipyridamole/aspirin
aspirin
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Arteriosclerosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • 9.169.02 St. James' Hospital
  • 9.169.01 Dept of Clinical Pharmacology

Outcomes

Primary Outcome Measures

platelet aggregation in response to arachidonic acid

Secondary Outcome Measures

platelet aggregation in response to epinephrine, adenosine diphosphate (ADP) and collagen
serum thromboxane B2
urinary 2,3,-dinor-6-keto-prostaglandin F1α
urinary 11-dehydro-thromboxane B2
plasma CD40L
flow cytometry measurements of platelet receptors in blood samples
bleeding time
6-keto-prostaglandin F1α (in bleeding time samples)
thromboxane B2 (in bleeding time samples)
flow cytometry measurements from bleeding time samples
coagulation markers F1.2 and fibrinopeptide A (in bleeding time samples)
pulse rate and blood pressure

Full Information

First Posted
August 10, 2005
Last Updated
October 28, 2013
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT00129038
Brief Title
Modified-release Dipyridamole/Aspirin (200mg/25mg bd) Versus Aspirin (75mg) in Aspirin-resistant Patients
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 Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Boehringer Ingelheim

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Arteriosclerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
modified-release dipyridamole/aspirin
Intervention Type
Drug
Intervention Name(s)
aspirin
Primary Outcome Measure Information:
Title
platelet aggregation in response to arachidonic acid
Time Frame
baseline, day 14, day 30 of each period
Secondary Outcome Measure Information:
Title
platelet aggregation in response to epinephrine, adenosine diphosphate (ADP) and collagen
Time Frame
baseline, day 14, day 30 of each period
Title
serum thromboxane B2
Time Frame
baseline, day 14, day 30 of each period
Title
urinary 2,3,-dinor-6-keto-prostaglandin F1α
Time Frame
baseline, day 30 of each period
Title
urinary 11-dehydro-thromboxane B2
Time Frame
baseline, day 30 of each period
Title
plasma CD40L
Time Frame
baseline, day 14, day 30 of each period
Title
flow cytometry measurements of platelet receptors in blood samples
Time Frame
baseline, day 14, day 30 of each period
Title
bleeding time
Time Frame
day 30 of each period
Title
6-keto-prostaglandin F1α (in bleeding time samples)
Time Frame
day 30 of each period
Title
thromboxane B2 (in bleeding time samples)
Time Frame
day 30 of each period
Title
flow cytometry measurements from bleeding time samples
Time Frame
day 30 of each period]
Title
coagulation markers F1.2 and fibrinopeptide A (in bleeding time samples)
Time Frame
day 30 of each period
Title
pulse rate and blood pressure
Time Frame
baseline, day 14, day 30 of each period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Organizational Affiliation
Boehringer Ingelheim
Official's Role
Study Chair
Facility Information:
Facility Name
9.169.02 St. James' Hospital
City
Dublin 8
Country
Ireland
Facility Name
9.169.01 Dept of Clinical Pharmacology
City
Dublin 9
Country
Ireland

12. IPD Sharing Statement

Links:
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/9/9.169_U08-2263.pdf
Description
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Modified-release Dipyridamole/Aspirin (200mg/25mg bd) Versus Aspirin (75mg) in Aspirin-resistant Patients

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