Coronary ArteriosclerosisPhase 4NCT00129038
Modified-release Dipyridamole/Aspirin (200mg/25mg bd) Versus Aspirin (75mg) in Aspirin-resistant Patients
A Phase 4 study testing modified-release dipyridamole/aspirin and aspirin in people with Coronary Arteriosclerosis, run by Boehringer Ingelheim at 2 sites in Ireland.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Arteriosclerosis
- What is being tested?
- modified-release dipyridamole/aspirin and aspirin
- How many people
- 11 participants
- Where
- 2 sitesIreland
- Study dates
- 1 Apr 2004to 1 Jan 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country.
Ireland2 sites
9.169.01 Dept of Clinical Pharmacology
Dublin
9.169.02 St. James' Hospital
Dublin
About this study
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.
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
- Conditions
- Coronary Arteriosclerosis
- Being tested
- modified-release dipyridamole/aspirin, aspirin
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
modified-release dipyridamole/aspirinDrug
aspirinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
platelet aggregation in response to arachidonic acid
Measured: baseline, day 14, day 30 of each period
Secondary outcomes (12)
platelet aggregation in response to epinephrine, adenosine diphosphate (ADP) and collagen
Measured: baseline, day 14, day 30 of each period
serum thromboxane B2
Measured: baseline, day 14, day 30 of each period
urinary 2,3,-dinor-6-keto-prostaglandin F1α
Measured: baseline, day 30 of each period
urinary 11-dehydro-thromboxane B2
Measured: baseline, day 30 of each period
plasma CD40L
Measured: baseline, day 14, day 30 of each period
flow cytometry measurements of platelet receptors in blood samples
Measured: baseline, day 14, day 30 of each period
bleeding time
Measured: day 30 of each period
6-keto-prostaglandin F1α (in bleeding time samples)
Measured: day 30 of each period
thromboxane B2 (in bleeding time samples)
Measured: day 30 of each period
flow cytometry measurements from bleeding time samples
Measured: day 30 of each period]
coagulation markers F1.2 and fibrinopeptide A (in bleeding time samples)
Measured: day 30 of each period
pulse rate and blood pressure
Measured: baseline, day 14, day 30 of each period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2005 (estimated)
- Study start1 Apr 2004
- Primary completion1 Jan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary ArteriosclerosisStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00129038
- Sponsor's protocol ID
- 9.169
- Status last verified
- Jan 2025
- First submitted
- 10 Aug 2005
- Last updated
- 23 Jan 2025
- Results posted
- No
- Individual data sharing
- No: Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00129038
- Acronym / sponsor ID
- 9.169
- Conditions
- Coronary Arteriosclerosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 1 Apr 2004 (actual)
- Primary completion
- 1 Jan 2007 (actual)
- First posted
- 11 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| modified-release dipyridamole/aspirin | Drug | – |
| aspirin | Drug | – |
Primary outcome
platelet aggregation in response to arachidonic acid
Time frame: baseline, day 14, day 30 of each period
12 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2025.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Boehringer Ingelheim study chair
Boehringer Ingelheim
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing modified-release dipyridamole/aspirin and aspirin in people with Coronary Arteriosclerosis, run by Boehringer Ingelheim at 2 sites in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
platelet aggregation in response to arachidonic acid (time frame: baseline, day 14, day 30 of each period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2025.