Platelet Dysfunction Due to Drugs Clinical Trial
Official title:
The Effects of loW Dose tIcagrelor on Platelet Function Testing in Patients With Stable Coronary arTery Disease: TWIST Trial
This study aims to assess the effects of low dose ticagrelor on platelet function testing in patients with stable coronary artery disease.
Dual antiplatelet therapy with aspirin and clopidogrel represents the standard of care for
the prevention of recurrent ischemic events in patients undergoing percutaneous coronary
intervention (PCI). For more than 20 years, dual antiplatelet therapy with aspirin and
Clopidogrel has remained the cornerstone of treatment for patients with acute coronary
syndrome (ACS). However, some patients have impaired clopidogrel response and thus persist
with high on-treatment platelet reactivity (HPR) resulting in an increased risk of
atherothrombotic events. The boxed warning added to the clopidogrel label underscoring the
potential risk of adverse cardiovascular outcomes among patients with a "poor metabolizer"
genotype and advocating the use of other antiplatelet medications or alternative dosing
strategies for these patients has led to investigations of treatment options associated with
more optimal platelet inhibition. These include switching to a novel generation P2Y12
inhibitor (e.g. prasugrel or ticagrelor).
Ticagrelor is an antagonist of the P2Y12 receptor. The drug was approved for use in the
European Union by the European Medicines Agency on December 3, 2010. The drug was approved by
the US Food and Drug Administration on July 20, 2011. The FDA indication for ticagrelor is a
reduction of the rate of cardiovascular death, myocardial infarction (MI), and stroke in
people with an acute coronary syndrome or history of myocardial infarction.
According to ESC 2017 guidelines, ticagrelor is the first-option treatment in patients with
acute coronary syndrome with or without ST-segment elevation, irrespective of treatment
strategy (invasive or non-invasive) - IB level of evidence. Furthermore, the 2017 ESC Focused
Update on Duration of Dual Antiplatelet Therapy allows physicians to administer ticagrelor to
patients with stable coronary artery disease undergoing percutaneous coronary intervention
after taking thrombotic and hemorrhagic risk into consideration.
In healthy Chinese subjects, low-dose ticagrelor produced an antiplatelet efficacy similar to
that of standard-dose ticagrelor, which was faster and more potent than the effect of
clopidogrel. In the East Asian population, there is limited evidence available to date that
compares low versus standard doses of ticagrelor to evaluate the clinical efficacy and
safety. Larger and longer duration studies are warranted to more closely examine the
appropriateness of lower doses of ticagrelor in this population.
The investigators postulate that inhibition of platelet aggregation in response to low dose
Ticagrelor as opposed to the standard dose is non-inferior to that of Clopidogrel.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02979158 -
Preoperative Dual Antiplatelet Therapy: Platelet Function and Influence of Cardiopulmonary Bypass
|
N/A | |
| Withdrawn |
NCT03338660 -
Platelet Function With Various Storage Techniques
|
Phase 2 | |
| Completed |
NCT03603249 -
Trimetazidine as an Adjunct to Enhance Clopidogrel Response.
|
Phase 2 | |
| Completed |
NCT03111420 -
Study of AggreGuide A-100 (ADP) Assay
|
N/A | |
| Recruiting |
NCT03005704 -
Reversal of the Antiplatelet Effects of Ticagrelor in Combination With Aspirin, Using Normal Platelets
|
N/A | |
| Recruiting |
NCT06228820 -
Aspirin Resistance in Trinidad.
|
Phase 2 | |
| Completed |
NCT04342819 -
The Effect of empagliFlozin on Platelet Function profilEs in diabetiC patienTs - The EFFECT Study.
|
Phase 2/Phase 3 | |
| Completed |
NCT03121898 -
PLATelet Function Operating Room Monitoring
|
||
| Active, not recruiting |
NCT03787927 -
Reversal of Dual Antiplatelet Therapy With Cold Stored Platelets
|
Phase 1/Phase 2 | |
| Withdrawn |
NCT02974777 -
The IDEAL-PCI Extended Registry
|
Phase 4 |