Platelet Aggregation and Adenosine Levels Among Patients Taking Ticagrelor or Prasugrel

Sponsor

University of Sao Paulo (Other)

Overall Status

Completed

CT.gov ID

NCT05247385

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease	Drug: Prasugrel Drug: Ticagrelor	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

87 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 20, 2017

Actual Primary Completion Date :

Feb 26, 2021

Actual Study Completion Date :

Dec 20, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Heart Institute (InCor) / University of São Paulo	São Paulo	Sao Paulo	Brazil	05403-000

Sponsors and Collaborators

University of Sao Paulo

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jose Carlos Nicolau, Director Coronary Care Unit, University of Sao Paulo

ClinicalTrials.gov Identifier:

NCT05247385

Other Study ID Numbers:

4086/14/066

First Posted:

Feb 18, 2022

Last Update Posted:

Feb 18, 2022

Last Verified:

Feb 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Coronary Artery Disease

Myocardial Ischemia

Coronary Disease

Ticagrelor

Prasugrel Hydrochloride

Study Results

No Results Posted as of Feb 18, 2022