Platelet Aggregation and Adenosine Levels Among Patients Taking Ticagrelor or Prasugrel

February 9, 2022 updated by: Jose Carlos Nicolau, University of Sao Paulo

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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

Study Type

Interventional

Enrollment (Actual)

87

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Sao Paulo
      • São Paulo, Sao Paulo, Brazil, 05403-000
        • Heart Institute (InCor) / University of São Paulo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Prasugrel group

Prasugrel (60mg loading dose, followed by 10 mg QD for 15 days)

+ Ticagrelor placebo (Placebo loading dose followed by two pills a day)
Drug: Prasugrel
Compared platelet inhibition and adenosine levels at baseline and after 15 days
Drug: Ticagrelor
Compared platelet inhibition and adenosine levels at baseline and after 15 days
Active Comparator: Ticagrelor group

Ticagrelor (180mg loading dose, followed by 90 mg BID)

+ Prasugrel placebo (Placebo loading dose followed by one pill a day)
Drug: Prasugrel
Compared platelet inhibition and adenosine levels at baseline and after 15 days
Drug: Ticagrelor
Compared platelet inhibition and adenosine levels at baseline and after 15 days

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 20, 2017

Primary Completion (Actual)

February 26, 2021

Study Completion (Actual)

December 20, 2021

Study Registration Dates

First Submitted

January 4, 2022

First Submitted That Met QC Criteria

February 9, 2022

First Posted (Actual)

February 18, 2022

Study Record Updates

Last Update Posted (Actual)

February 18, 2022

Last Update Submitted That Met QC Criteria

February 9, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4086/14/066 (CAPPesq)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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