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NCT05247385 Clinical Trial

Platelet Aggregation and Adenosine Levels Among Patients Taking Ticagrelor or Prasugrel

Coronary Artery Disease Clinical Trial

Official title:
Platelet Aggregation and Adenosine Levels Among Patients With Stable Chronic Coronary Artery Disease Taking Ticagrelor or Prasugrel

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05247385
Other study ID # 4086/14/066
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date March 20, 2017
Est. completion date December 20, 2021

Study information
Verified date February 2022
Source University of Sao Paulo
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Prospective, single-center, double blind, double dummy, randomized trial. Platelet function tests and adenosine levels were assessed at baseline and 15 days after taking Ticagrelor with Prasugrel placebo or Prasugrel with Ticagrelor placebo in stable patients with coronary artery disease

Description:

This was a prospective, double blinded, randomized trial that compared platelet inhibition and adenosine levels with ticagrelor (180mg loading dose, followed by 90 mg BID) versus prasugrel (60mg loading dose, followed by 10 mg QD) . Patients were eligible if they were between 18 and 75 years old, were on aspirin without P2Y12 inhibitor at baseline and > 1 year after documented ACS. Platelet aggregation was compared with the Multiplate ADP® assay, performed at baseline and after 15 days on study medication. Adenosine plasma levels were measured with high performance liquid chromatography at the same time points

Recruitment information / eligibility
Status Completed
Enrollment 87
Est. completion date December 20, 2021
Est. primary completion date February 26, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - between 18 and 75 years old - were on aspirin - without P2Y12 inhibitor at baseline - > 1 year after documented acute coronary syndrome Exclusion Criteria: - use of oral anticoagulation or P2Y12 at baseline - Weight < 60kg - History of tia or stroke - Any coagulation disorders - Refuse to sign the written consent

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Prasugrel
Compared platelet inhibition and adenosine levels at baseline and after 15 days
• Ticagrelor
Compared platelet inhibition and adenosine levels at baseline and after 15 days

Locations
Country Name City State
Brazil Heart Institute (InCor) / University of São Paulo São Paulo Sao Paulo

Sponsors (1)
Lead Sponsor Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome
Type Measure Description Time frame Safety issue
Primary To compare platelet inhibition between the two groups (ticagrelor and prasugrel) Platelet aggregation was compared with the Multiplate ADP® assay at baseline and after 15 days on study medication 15 days
Primary To compare adenosine levels between the two groups (ticagrelor and prasugrel) Adenosine plasma levels were measured at baseline and after 15 days with high performance liquid chromatography at the same time points 15 days
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