Platelet Dysfunction Due to Drugs Clinical Trial
Official title:
Aspirin Resistance in Trinidad: The ART Pilot Study.
Aspirin's beneficial effect is mediated via the inhibition of arachidonic acid (AA) activation of platelets. It is detected by demonstrating a decrease in platelet function and/or a decrease in prostaglandin metabolites. Besides inhibiting the formation of thromboxane A2 from arachidonic acid, Aspirin has a host of platelet-independent effects that complement its platelet-inhibitory effects. The phenomenon of "Aspirin resistance" is based on the observation of clinical events in some patients taking Aspirin and/or a diminished platelet aggregation inhibitory response to Aspirin therapy. It has been suggested that many individuals taking Aspirin have become resistant to this drug. Unfortunately, laboratory assays used to monitor the efficacy of Aspirin are far from accurate, and the results are not reproducible. Multiple studies demonstrate non-compliance using repeat testing for platelet inhibition in patients with an initial inadequate response to Aspirin. When the test is repeated under the condition that the ingestion of the test Aspirin is assured, the patients' platelets are inhibited. Patients with an inadequate Aspirin response have an increased likelihood of subsequent vascular events.
Aspirin is a wonder drug used for over 100 years for its analgesic and antipyretic effects. It is an inexpensive, readily available medication that reduces the risk of subsequent vascular disease by about 25% in patients with known occlusive vascular disease. For the past three decades, it has increasingly been used to prevent primary and secondary cardiovascular events. Aspirin's beneficial effect is mediated via the inhibition of arachidonic acid (AA) activation of platelets. It is detected by demonstrating a decrease in platelet function and/or a decrease in prostaglandin metabolites. Besides inhibiting the formation of thromboxane A2 from arachidonic acid, Aspirin has a host of platelet-independent effects that complement its platelet-inhibitory effects. The phenomenon of "Aspirin resistance" is based on the observation of clinical events in some patients taking Aspirin and/or a diminished platelet aggregation inhibitory response to Aspirin therapy. It has been suggested that many individuals taking Aspirin have become resistant to this drug. Unfortunately, laboratory assays used to monitor the efficacy of Aspirin are far from accurate, and the results are not reproducible. Multiple studies demonstrate non-compliance using repeat testing for platelet inhibition in patients with an initial inadequate response to Aspirin. When the test is repeated under the condition that the ingestion of the test Aspirin is assured, the patients' platelets are inhibited. Patients with an inadequate Aspirin response have an increased likelihood of subsequent vascular events. The POINT pilot study introduced the preliminary observation that the estimated prevalence of HPR is considerably higher within the heterogeneous population in Trinidad at 50% compared with predominantly Caucasian studies. Furthermore, the HPR is significantly higher in South Asians (Indo-Trinidadians) (>60% of patients), which has severe clinical repercussions considering the cardiovascular disease pandemic. Clopidogrel may not be a satisfactory or optimal antiplatelet agent in this subgroup. Therefore, another more potent antiplatelet, such as ticagrelor, should be used instead. Patients generally displayed a limited level of cardiovascular medication adherence, which is likely to translate into a higher rate of cardiovascular events with their potentially devastating sequelae. We postulate that there is a high level of Aspirin resistance in Trinidad and Tobago. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04206176 -
The Effects of loW Dose tIcagrelor on Platelet Function Testing in Patients With Stable Coronary arTery Disease
|
Phase 1/Phase 2 | |
| 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 | |
| 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 |