Platelet Aggregation and Adenosine Levels Among Patients Taking Ticagrelor or Prasugrel

Phase 4

Completed

• Conditions: Coronary Artery Disease
• Interventions: Drug: Prasugrel; Drug: Ticagrelor

• Registration Number: NCT05247385
• Lead Sponsor: University of Sao Paulo

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

Study Timeline

• Study Start: 2017-03-20
• Primary Completion: 2021-02-26
• Study Completion: 2021-12-20
• Study First Submitted: 2022-01-04
• Status Verified: 2022-02
• Study First Submitted QC: 2022-02-09
• Last Update Submitted: 2022-02-09
• Study First Posted: 2022-02-18
• Last Update Posted: 2022-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 87

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prasugrel group	Prasugrel	Prasugrel (60mg loading dose, followed by 10 mg QD for 15 days) + Ticagrelor placebo (Placebo loading dose followed by two pills a day)
Prasugrel group	Ticagrelor	Prasugrel (60mg loading dose, followed by 10 mg QD for 15 days) + Ticagrelor placebo (Placebo loading dose followed by two pills a day)
Ticagrelor group	Prasugrel	Ticagrelor (180mg loading dose, followed by 90 mg BID) + Prasugrel placebo (Placebo loading dose followed by one pill a day)
Ticagrelor group	Ticagrelor	Ticagrelor (180mg loading dose, followed by 90 mg BID) + Prasugrel placebo (Placebo loading dose followed by one pill a day)

Primary Outcome Measures

Name	Time	Method
To compare platelet inhibition between the two groups (ticagrelor and prasugrel)	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)	15 days	Adenosine plasma levels were measured at baseline and after 15 days with high performance liquid chromatography at the same time points

Trial Locations

Locations (1)

Heart Institute (InCor) / University of São Paulo; 🇧🇷 São Paulo, Sao Paulo, Brazil