Clinical trial NCT00129038: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Arteriosclerosis
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2005-08-11
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: platelet aggregation in response to arachidonic acid
timeFrame: baseline, day 14, day 30 of each period
Secondary outcomes:
measure: platelet aggregation in response to epinephrine, adenosine diphosphate (ADP) and collagen
timeFrame: baseline, day 14, day 30 of each period
measure: serum thromboxane B2
timeFrame: baseline, day 14, day 30 of each period
measure: urinary 2,3,-dinor-6-keto-prostaglandin F1α
timeFrame: baseline, day 30 of each period
measure: urinary 11-dehydro-thromboxane B2
timeFrame: baseline, day 30 of each period
measure: plasma CD40L
timeFrame: baseline, day 14, day 30 of each period
measure: flow cytometry measurements of platelet receptors in blood samples
timeFrame: baseline, day 14, day 30 of each period
measure: bleeding time
timeFrame: day 30 of each period
measure: 6-keto-prostaglandin F1α (in bleeding time samples)
timeFrame: day 30 of each period
measure: thromboxane B2 (in bleeding time samples)
timeFrame: day 30 of each period
measure: flow cytometry measurements from bleeding time samples
timeFrame: day 30 of each period]
measure: coagulation markers F1.2 and fibrinopeptide A (in bleeding time samples)
timeFrame: day 30 of each period
measure: pulse rate and blood pressure
timeFrame: baseline, day 14, day 30 of each period
Other outcomes:
Locations:
city: Dublin 8
country: Ireland
facility: 9.169.02 St. James' Hospital
city: Dublin 9
country: Ireland
facility: 9.169.01 Dept of Clinical Pharmacology
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: