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

Coronary Arteriosclerosis Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00129038
• Other study ID #: 9.169
• Status: Completed
• Phase: Phase 4
• First received: August 10, 2005
• Last updated: October 28, 2013
• Start date: April 2004

Study information

• Verified date: October 2013
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ireland: Irish Medicines Board
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. primary completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arteriosclerosis
• Coronary Arteriosclerosis
• Coronary Artery Disease
• Myocardial Ischemia

Intervention

Drug:
• modified-release dipyridamole/aspirin

• aspirin

Locations

Country	Name	City	State
Ireland	9.169.02 St. James' Hospital	Dublin 8
Ireland	9.169.01 Dept of Clinical Pharmacology	Dublin 9

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	platelet aggregation in response to arachidonic acid		baseline, day 14, day 30 of each period	No
Secondary	platelet aggregation in response to epinephrine, adenosine diphosphate (ADP) and collagen		baseline, day 14, day 30 of each period	No
Secondary	serum thromboxane B2		baseline, day 14, day 30 of each period	No
Secondary	urinary 2,3,-dinor-6-keto-prostaglandin F1a		baseline, day 30 of each period	No
Secondary	urinary 11-dehydro-thromboxane B2		baseline, day 30 of each period	No
Secondary	plasma CD40L		baseline, day 14, day 30 of each period	No
Secondary	flow cytometry measurements of platelet receptors in blood samples		baseline, day 14, day 30 of each period	No
Secondary	bleeding time		day 30 of each period	No
Secondary	6-keto-prostaglandin F1a (in bleeding time samples)		day 30 of each period	No
Secondary	thromboxane B2 (in bleeding time samples)		day 30 of each period	No
Secondary	flow cytometry measurements from bleeding time samples		day 30 of each period]	No
Secondary	coagulation markers F1.2 and fibrinopeptide A (in bleeding time samples)		day 30 of each period	No
Secondary	pulse rate and blood pressure		baseline, day 14, day 30 of each period	No

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