|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | August 10, 2005 | ||||
| Last Updated Date | July 2, 2009 | ||||
| Start Date ICMJE | April 2004 | ||||
| Primary Completion Date | January 2007 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE |
The primary endpoint will be the proportion of patients classified as aspirin-resistant at the end of each treatment period (i.e. day 30) | ||||
| Change History | Complete list of historical versions of study NCT00129038 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE |
Serum thromboxane B2, platelet aggregation (after epinephrine, ADP or collagen), plasma CD40L, markers of platelet activation, urine prostaglandins, bleeding time, blood prostaglandins and markers of blood coagulation | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Modified-Release Dipyridamole/Aspirin (200mg/25mg bd) Versus Aspirin (75mg) in Aspirin-Resistant Patients | ||||
| Official Title ICMJE | 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. | ||||
| 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 |
||||
| Detailed Description | |||||
| Study Phase | Phase IV | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment | ||||
| Condition ICMJE | Coronary Arteriosclerosis | ||||
| Intervention ICMJE |
|
||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
|
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 11 | ||||
| Completion Date | |||||
| Primary Completion Date | January 2007 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Ireland | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00129038 | ||||
| Responsible Party | Boehringer Ingelheim, Study Chair, Boehringer Ingelheim | ||||
| Study ID Numbers ICMJE | 9.169 | ||||
| Study Sponsor ICMJE | Boehringer Ingelheim Pharmaceuticals | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
|
||||
| Information Provided By | Boehringer Ingelheim Pharmaceuticals | ||||
| Verification Date | July 2009 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||