Platelet Sub-study of the Neomindset Trial

April 4, 2025 updated by: Hospital Israelita Albert Einstein

Platelet Function Evaluation in Patients With Acute Coronary Syndromes on Potent P2Y12 Inhibitor Monotherapy Versus Dual Antiplatelet Therapy With Aspirin and a Potent P2Y12 Inhibitor

The general purpose of the Neomindset trial is to evaluate the non-inferiority hypothesis for ischemic events and the superiority hypothesis for bleeding events resulting from platelet P2Y12 receptor inhibitors given as monotherapy in comparison with conventional dual antiplatelet therapy in acute coronary syndrome patients treated with percutaneous coronary intervention.

The platelet sub-study will be conducted at the Hospital Israelita Albert Einstein. This sub-study will recruit randomized patients from the Neomindset trial to evaluate platelet function after at least 30 days of study treatment with either P2Y12 inhibitor monotherapy or dual antiplatelet therapy.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The platelet sub-study will be conducted at the Hospital Israelita Albert Einstein. This sub-study will recruit randomized patients from the Neomindset trial to evaluate platelet function after at least 30 days of study treatment with either P2Y12 inhibitor monotherapy or dual antiplatelet therapy.

These patients will undergo blood sampling and measurement of platelet function after being treated with P2Y12 inhibitor monotherapy or dual antiplatelet therapy for at least 30 days.

Study Type

Interventional

Enrollment (Estimated)

48

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
      • São Paulo, Brazil
        • Hospital Israelita Albert Einstein

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion criteria:

  • Age >=18 years;
  • Clinical presentation compatible with acute coronary syndrome with onset < 24 hours before admission;
  • Successful percutaneous coronary intervention(s) of all target lesions (culprit and non-culprit) with new-generation drug-eluting stents;
  • Length of stay in hospital at randomization < 96 hours;
  • Subjects will be informed about the nature of the study and must agree to comply and give an informed consent in writing using a form approved in advance by the local Ethics Committee.

Exclusion Criteria:

  • Acute coronary syndrome on index admission treated in a conservative way or by unsuccessful percutaneous intervention or surgically;
  • Presence of residual lesions which are likely to require future treatment in the next 12 months;
  • Fibrinolytic therapy < 24 hour before randomization;
  • Need of oral anticoagulation with warfarin or new anticoagulants;
  • Chronic bleeding diathesis;
  • Active or recent major bleeding (in-hospital);
  • Prior intracranial hemorrhage;
  • Ischemic cerebrovascular accident < 30 days;
  • Presence of brain arteriovenous malformation;
  • Index event of non-atherothrombotic etiology (i.e., stent thrombosis, coronary embolism, spontaneous coronary artery dissection, myocardial ischemia due to supply/demand imbalance);
  • Potential or scheduled cardiac or non-cardiac surgery in the next 12 months;
  • Platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3;
  • Total white blood count < 3,000 cells/mm3;
  • Suspected or documented active liver disease (including laboratory evidence of hepatitis B or C);
  • Receiver of heart transplant;
  • Known allergies or intolerance of acetylsalicylic acid, clopidogrel, ticlopidine, ticagrelor, prasugrel, heparin or antiproliferative agents from the limus-family of drugs;
  • Subject with life expectation lower than 1 year;
  • Any significant medical condition that, in the investigator's opinion, could interfere with the ideal participation of the subject in the study;
  • Participation in other study in the past 12 months, unless a direct benefit to the subject can be expected.
  • Impossibility of being treated with dual antiplatelet therapy for 12 months, based on investigator judgement.

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: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Acetylsalicylic acid + ticagrelor OR Acetylsalicylic acid + prasugrel

Subjects randomized to Dual Antiplatelet Therapy Control Group will be treated with a regimen of acetylsalicylic acid combined with ticagrelor or prasugrel for 12 months.

Acetylsalicylic acid (100 mg/day) + ticagrelor (90 mg twice daily) Or Acetylsalicylic acid (100 mg/day) + prasugrel (10 mg once daily)
Drug: Dual antiplatelet therapy: Acetylsalicylic acid + ticagrelor OR Acetylsalicylic acid + prasugrel
Acetylsalicylic acid (100 mg/day) + ticagrelor (90 mg twice daily) Or Acetylsalicylic acid (100 mg/day) + prasugrel (10 mg once daily)
Other Names:
  • Dual Antiplatelet Therapy
Experimental: Ticagrelor alone or prasugrel alone

All subjects randomized to Monotherapy Group will have acetylsalicylic acid discontinued immediately after randomization.

Subjects randomized to Monotherapy Group will be treated with ticagrelor (90 mg twice daily) or prasugrel alone (10 mg once daily) for 12 months.

Ticagrelor alone (90 mg twice daily) Or Prasugrel alone (10 mg once daily)
Drug: Monotherapy: Ticagrelor alone OR Prasugrel alone
Ticagrelor alone (90 mg twice daily) OR Prasugrel alone (10 mg once daily)
Other Names:
  • Monotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Platelet function using PFA-100
Time Frame: 30 days of treatment
Platelet function using PFA-100
30 days of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Platelet function using CHRONO-LOG
Time Frame: 30 days of treatment
Platelet function using CHRONO-LOG
30 days of treatment
Platelet function using Rotem-platelet
Time Frame: 30 days of treatment
Platelet function using Rotem-platelet
30 days of treatment
Coagulation test using thromboelastogram
Time Frame: 30 days of treatment
Coagulation test using thromboelastogram
30 days of treatment

Collaborators and Investigators

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

Sponsor

Hospital Israelita Albert Einstein

Investigators

  • Principal Investigator: Pedro A Lemos, MD, PhD, Hospital Israelita Albert Einstein

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

February 6, 2023

Primary Completion (Estimated)

May 30, 2025

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

February 15, 2023

First Submitted That Met QC Criteria

March 2, 2023

First Posted (Actual)

March 14, 2023

Study Record Updates

Last Update Posted (Actual)

April 8, 2025

Last Update Submitted That Met QC Criteria

April 4, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Platelet

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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