NCT Number: NCT00129038
Modified-release Dipyridamole/Aspirin (200mg/25mg bd) Versus Aspirin (75mg) in Aspirin-resistant Patients
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
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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 4
Primary location
9.169.01 Dept of Clinical Pharmacology, Dublin, Ireland
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Aspirin
DrugPrimary outcomes
-
platelet aggregation in response to arachidonic acid
Time frame: baseline, day 14, day 30 of each period
Secondary outcomes
-
platelet aggregation in response to epinephrine, adenosine diphosphate (ADP) and collagen
Time frame: baseline, day 14, day 30 of each period
-
serum thromboxane B2
Time frame: baseline, day 14, day 30 of each period
-
urinary 2,3,-dinor-6-keto-prostaglandin F1α
Time frame: baseline, day 30 of each period
-
urinary 11-dehydro-thromboxane B2
Time frame: baseline, day 30 of each period
-
plasma CD40L
Time frame: baseline, day 14, day 30 of each period
-
flow cytometry measurements of platelet receptors in blood samples
Time frame: baseline, day 14, day 30 of each period
-
bleeding time
Time frame: day 30 of each period
-
6-keto-prostaglandin F1α (in bleeding time samples)
Time frame: day 30 of each period
-
thromboxane B2 (in bleeding time samples)
Time frame: day 30 of each period
-
flow cytometry measurements from 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
-
pulse rate and blood pressure
Time frame: baseline, day 14, day 30 of each period
Sponsors and collaborators
Lead sponsor
Boehringer Ingelheim
Industry
Registry information
Official study 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.
Important dates
- Study start
- 2004
- Primary completion
- 2007
- First posted
- Aug 11, 2005
- Registry last updated
- Jan 23, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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