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Platelet Reactivity clinical trials

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NCT ID: NCT05773989 Recruiting - Clinical trials for Coronary Artery Disease

Pharmacodynamic Outcomes in CCS Patients Treated With an Individualized Treatment Strategy

Start date: January 23, 2024
Phase: Phase 4
Study type: Interventional

Patients with Chronic Coronary Syndrome (CCS) undergoing with elective percutaneous coronary intervention (PCI) are treated with dual antiplatelet therapy (DAPT), consisting of aspirin combined with clopidogrel for 6 months. The aim of DAPT is to prevent recurrent thrombotic events, i.e. death, stent thrombosis and/ or myocardial infarction (MI). However, the trade-off of thrombotic prevention by DAPT is an increased risk of bleeding. Multiple strategies to reduce bleeding risk and optimize outcomes have been proposed. On one hand the bleeding risk can be reduced by shortening the duration of DAPT and omitting aspirin. This has been proven effective in patients with acute coronary syndromes (ACS) compared to standard DAPT, without a significant difference in thrombotic events. On the other hand, personalized medicine by means of genotyping to ensure that a patient is treated with an, for them, effective drug, can be a strategy to optimize patients outcomes. In CCS patients the preferred P2Y12-inhibitor is clopidogrel. However, clopidogrel must first be activated by the CYP2C19 enzyme in the liver. Only then can clopidogrel inhibit the P2Y12-receptor and prevent platelet activation. Almost thirty percent of patients has a genetic variation of the gene encoding this CYP2C19 enzyme. In these patients, clopidogrel is not or hardly activated, putting them at a higher risk of thrombotic events than patients who do not have this gene variation. By determining the CYP2C19 genotype, it is possible to estimate whether clopidogrel will be effective or not. In this trial the investigators evaluate the pharmacodynamic effects of genotype guided P2Y12-inhibitor monotherapy in patients with CCS undergoing PCI. In the intervention arm the CYP2C19 genotype will be assessed using a point-of-care test device on the cardiology ward, which can be performed by (research) nurses. Patients with a CYP2C19 loss-of-function (LOF) allel will be treated with monotherapy ticagrelor or prasugrel. Patients who are non-carrier of a LOF allel will receive clopidogrel. The control arm will be treated with the current standard-of-care, which is DAPT, consisting of aspirin combined with clopidogrel for 6 months. The main goals is to assess the antithrombotic effects of individualized P2Y12 monotherapy strategy versus clopidogrel plus aspirin in elective PCI patients.

NCT ID: NCT05657041 Recruiting - Clinical trials for Coronary Artery Disease

Body Weight Adjusted Clopidogrel Treatment in Patients With CORonary Artery Disease

BW-ACCORD
Start date: April 26, 2023
Phase: Phase 2/Phase 3
Study type: Interventional

Extreme body weights (BW) or body mass index (BMI) affect the pharmacokinetics of antithrombotic drugs and consequently may affect cardiovascular risk during treatment. The goal of this clinical trial is to establish if clopidogrel treatment can be optimized in patients with a low or high BW compared to patients with a normal BW by adjusting the dosage of clopidogrel and evaluating platelet reactivity. Participants are stratified into three groups based on their BW (Low BW: BW <60kg; normal BW: 60-100kg; High BW: >100 kg) Clopidogrel dosage will then be adjusted to the BW, as follows: - Low BW: >10 days clopidogrel 50mg 1dd1, followed by >10 days clopidogrel 25mg 1dd1. - Normal BW: Clopidogrel 75mg 1dd1. - High BW: >10 days clopidogrel 150mg 1dd1 followed by >10 days prasugrel 10mg 1dd1. The primary endpoint of the study is P2Y12 Reaction Units (PRU) and platelet inhibition measured using the VerifyNow measured before starting new treatment regimen (at the end of 10 days of treatment).

NCT ID: NCT05367336 Recruiting - Fentanyl Clinical Trials

Platelet Reactivity With Fentanyl, Morphine, or no Narcotic

Start date: August 31, 2022
Phase: Early Phase 1
Study type: Interventional

The goal is to determine whether fentanyl and morphine have similar effects in reducing aspirin's effect upon platelets in emergency department patients with chest discomfort. Morphine has been shown to worsen outcomes in heart attack patients due to reduction of oral anti-platelet agent effectiveness and so many providers have switches to using fentanyl. However, it is largely unknown whether fentanyl has similar effects.

NCT ID: NCT03614832 Recruiting - Platelet Reactivity Clinical Trials

Ticagrelor and Clopidogrel on Platelet Aggregation in Clopidogrel Resistance's Patients With CHD

Start date: May 1, 2018
Phase: Phase 4
Study type: Interventional

The study sought to observe the effects of optimal dose of ticagrelor(90 mg qd)ticagrelor and double standard-dose clopidogrel on platelet reactivity in coronary heart disease patients with high on-treatment platelet reactivity (HTPR) while on clopidogrel. HTPR with clopidogrel administration in coronary heart disease (CHD) patients has associated with an increased risk of adverse events. Newer P2Y12 inhibitors ticagrelor (90mg BID) provide stronger platelet inhibition compared with clopidogrel, but a low-dose of ticagrelor (90mg QD) has not been previously studied in Chinese CHD patients with HTPR.

NCT ID: NCT03525145 Recruiting - Clinical trials for Acute Coronary Syndrome

Platelet Reactivity And Clinical ThrombotIC Events Study

PRACTICE
Start date: September 1, 2018
Phase:
Study type: Observational [Patient Registry]

Platelet function testing has been considered for DAPT strategy adjustments to reduce the patient's risk of ischemia and bleeding. Although several previous RCT studies did not find any benefit in the detection of platelet function, the previous studies were mostly low-risk populations, and the P2Y12 receptor antagonists were simply clopidogrel, and the detection methods were relatively simple. Therefore, the need for platelet monitoring in high-risk ACS patients receiving new potent P2Y12 inhibitor ticagrelor, as well as the diagnostic threshold for different platelet function assays needs further study. In addition, due to the differences on the response to anti-platelet drugs between the East and the West, it is not appropriate to simply refer to the conclusion of the other party. However, as of now, there is no large sample randomized controlled study systematically focused on the applicability and status of platelet function tests in East Asian populations, especially Chinese populations.