PPARGC1β and CNTN4 Genotype Aspirin Study
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|ClinicalTrials.gov Identifier: NCT02970604|
Recruitment Status : Unknown
Verified November 2016 by Royal College of Surgeons, Ireland.
Recruitment status was: Recruiting
First Posted : November 22, 2016
Last Update Posted : November 22, 2016
Heart attacks and strokes are common causes of death worldwide. These events occur in part, due to increased activity of platelets, which cause clotting (thrombosis) within heart and brain blood vessels.
Anti-platelet therapies (e.g. aspirin) reduce the likelihood of platelet thrombosis and therefore protect against heart attacks and strokes. However serious bleeding into the gut and brain occurs in a number of individuals prescribed aspirin. Currently, there is no reliable method for assessing the relative risks of thrombosis versus bleeding in individual patients prior to or during aspirin therapy.
We have recently discovered that individuals with a particular genetic make-up, those with genetic variants in two genes called PPARGC1β and CNTN4, demonstrate more active (sticky) platelets. We then found that these same individuals suffered a greater number of cardiovascular events. Interestingly, low dose aspirin suppressed the excessive platelet stickiness and protected against heart attacks and strokes in these patients.
In this project, we aim to confirm and extend the above findings. We hope that testing for PPARGC1β and CNTN4 genetic variants will allow us to identify which patients will benefit from low dose aspirin therapy - i.e. receive protection from heart attacks and strokes, but not suffer any bleeding complications.
|Condition or disease||Intervention/treatment||Phase|
|Cardiovascular Diseases||Drug: Aspirin||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||160 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||PPARGC1β And CNTN4 Genotype as a Pharmacogenetic Assay of Thrombosis and Bleeding Risks - a Cross-Over Controlled Trial of Aspirin in Individuals at Increased Cardiovascular Risk.|
|Study Start Date :||May 2016|
|Estimated Primary Completion Date :||February 2018|
|Estimated Study Completion Date :||February 2018|
Non-enteric coated Aspirin 75mg once daily for 7 days
Non enteric coated aspirin
No Intervention: No treatment
No treatment for 7 days
- Urinary Thromboxane B2/Creatinine Ratio [ Time Frame: Baseline ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02970604
|Contact: Kirstyn James, MB||0035318093706 ext email@example.com|
|Royal College of Surgeons in Ireland||Recruiting|
|Contact: Kirstyn James, MB 0035318093706 ext 3706 firstname.lastname@example.org|
|Principal Investigator:||Alice Stanton, MB PhD||Royal College of Surgeons in Ireland|