Ignite Creation Date:
2024-05-06 @ 8:01 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06228820
Status:
RECRUITING
Last Update Posted:
2024-01-29
First Post:
2024-01-18
Brief Title:
Aspirin Resistance in Trinidad
Sponsor:
The University of The West Indies
Organization:
The University of The West Indies
Study Overview
Official Title:
Aspirin Resistance in Trinidad The ART Pilot Study
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ART
Brief Summary:
Aspirins beneficial effect is mediated via the inhibition of arachidonic acid AA activation of platelets It is detected by demonstrating a decrease in platelet function andor 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 andor 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 phenomenon of Aspirin resistance is based on the observation of clinical events in some patients taking Aspirin andor 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
Detailed Description:
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
Aspirins beneficial effect is mediated via the inhibition of arachidonic acid AA activation of platelets It is detected by demonstrating a decrease in platelet function andor 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 andor 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
Aspirins beneficial effect is mediated via the inhibition of arachidonic acid AA activation of platelets It is detected by demonstrating a decrease in platelet function andor 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 andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None