Platelet Aggregation and Adenosine Levels Among Patients Taking Ticagrelor or Prasugrel

NCT ID: NCT05247385

Last Updated: 2022-02-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

87 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-20

Study Completion Date

2021-12-20

Brief Summary

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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

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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

Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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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)

Group Type ACTIVE_COMPARATOR

Prasugrel

Intervention Type DRUG

Compared platelet inhibition and adenosine levels at baseline and after 15 days

Ticagrelor

Intervention Type DRUG

Compared platelet inhibition and adenosine levels at baseline and after 15 days

Ticagrelor group

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

\+ Prasugrel placebo (Placebo loading dose followed by one pill a day)

Group Type ACTIVE_COMPARATOR

Prasugrel

Intervention Type DRUG

Compared platelet inhibition and adenosine levels at baseline and after 15 days

Ticagrelor

Intervention Type DRUG

Compared platelet inhibition and adenosine levels at baseline and after 15 days

Interventions

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Prasugrel

Compared platelet inhibition and adenosine levels at baseline and after 15 days

Intervention Type DRUG

Ticagrelor

Compared platelet inhibition and adenosine levels at baseline and after 15 days

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Jose Carlos Nicolau

Director Coronary Care Unit

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Heart Institute (InCor) / University of São Paulo

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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4086/14/066

Identifier Type: -

Identifier Source: org_study_id

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