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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00129038
• Date of registration: 10/08/2005
• Prospective Registration: No
• Primary sponsor: Boehringer Ingelheim
• Public title: Modified-release Dipyridamole/Aspirin (200mg/25mg bd) Versus Aspirin (75mg) in Aspirin-resistant Patients
• Scientific 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.
• Date of first enrolment: April 2004
• Target sample size: 11
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00129038
• Study type: Interventional
• Study design: Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

Ireland

Contacts

• Name: Boehringer Ingelheim
• Affiliation: Boehringer Ingelheim

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Coronary Arteriosclerosis

Intervention(s)

Drug: modified-release dipyridamole/aspirin

Drug: aspirin

Primary Outcome(s)

platelet aggregation in response to arachidonic acid [Time Frame: baseline, day 14, day 30 of each period]

Secondary Outcome(s)

serum thromboxane B2 [Time Frame: baseline, day 14, day 30 of each period]

bleeding time [Time Frame: day 30 of each period]

flow cytometry measurements of platelet receptors in blood samples [Time Frame: baseline, day 14, day 30 of each period]

6-keto-prostaglandin F1a (in bleeding time samples) [Time Frame: day 30 of each period]

coagulation markers F1.2 and fibrinopeptide A (in bleeding time samples) [Time Frame: day 30 of each period]

plasma CD40L [Time Frame: baseline, day 14, day 30 of each period]

platelet aggregation in response to epinephrine, adenosine diphosphate (ADP) and collagen [Time Frame: baseline, day 14, day 30 of each period]

urinary 2,3,-dinor-6-keto-prostaglandin F1a [Time Frame: baseline, day 30 of each period]

flow cytometry measurements from bleeding time samples [Time Frame: day 30 of each period]]

pulse rate and blood pressure [Time Frame: baseline, day 14, day 30 of each period]

thromboxane B2 (in bleeding time samples) [Time Frame: day 30 of each period]

urinary 11-dehydro-thromboxane B2 [Time Frame: baseline, day 30 of each period]

Secondary ID(s)

9.169

Source(s) of Monetary Support

Please refer to primary and secondary sponsors