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Clinical Trials/NCT05247385
NCT05247385
Completed
Phase 4

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

University of Sao Paulo1 site in 1 country87 target enrollmentMarch 20, 2017

Overview

Phase
Phase 4
Intervention
Prasugrel
Conditions
Coronary Artery Disease
Sponsor
University of Sao Paulo
Enrollment
87
Locations
1
Primary Endpoint
To compare platelet inhibition between the two groups (ticagrelor and prasugrel)
Status
Completed
Last Updated
4 years ago

Overview

Brief 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

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

Registry
clinicaltrials.gov
Start Date
March 20, 2017
End Date
December 20, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jose Carlos Nicolau

Director Coronary Care Unit

University of Sao Paulo

Eligibility Criteria

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

Arms & Interventions

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)

Intervention: Prasugrel

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)

Intervention: Ticagrelor

Ticagrelor group

Ticagrelor (180mg loading dose, followed by 90 mg BID) + Prasugrel placebo (Placebo loading dose followed by one pill a day)

Intervention: Prasugrel

Ticagrelor group

Ticagrelor (180mg loading dose, followed by 90 mg BID) + Prasugrel placebo (Placebo loading dose followed by one pill a day)

Intervention: Ticagrelor

Outcomes

Primary Outcomes

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

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

Study Sites (1)

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