Platelet Sub-study of the Neomindset Trial

NCT05767723 | Active Not Recruiting Phase 4

• 1 other identifier: Platelet
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Coronary Syndrome

Keywords

acute coronary syndrome; antithrombotic therapy; dual antiplatelet therapy; monotherapy

Outcome Measures

Primary Outcomes (1)

• Platelet function using PFA-100

  Platelet function using PFA-100

  30 days of treatment

Secondary Outcomes (3)

• Platelet function using CHRONO-LOG

  30 days of treatment

• Platelet function using Rotem-platelet

  30 days of treatment

• Coagulation test using thromboelastogram

  30 days of treatment

Study Arms (2)

Acetylsalicylic acid + ticagrelor OR Acetylsalicylic acid + prasugrel

ACTIVE COMPARATOR

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

Ticagrelor alone or prasugrel alone

EXPERIMENTAL

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

Interventions

Dual antiplatelet therapy: Acetylsalicylic acid + ticagrelor OR Acetylsalicylic acid + prasugrel DRUG

Acetylsalicylic acid (100 mg/day) + ticagrelor (90 mg twice daily) Or Acetylsalicylic acid (100 mg/day) + prasugrel (10 mg once daily)

Also known as: Dual Antiplatelet Therapy

Acetylsalicylic acid + ticagrelor OR Acetylsalicylic acid + prasugrel

Monotherapy: Ticagrelor alone OR Prasugrel alone DRUG

Ticagrelor alone (90 mg twice daily) OR Prasugrel alone (10 mg once daily)

Also known as: Monotherapy

Ticagrelor alone or prasugrel alone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Hospital Israelita Albert Einstein: lead

Study Sites (1)

Hospital Israelita Albert Einstein

São Paulo, Brazil

Location

Related Publications (3)

• Valgimigli M, Bueno H, Byrne RA, Collet JP, Costa F, Jeppsson A, Juni P, Kastrati A, Kolh P, Mauri L, Montalescot G, Neumann FJ, Petricevic M, Roffi M, Steg PG, Windecker S, Zamorano JL, Levine GN; ESC Scientific Document Group; ESC Committee for Practice Guidelines (CPG); ESC National Cardiac Societies. 2017 ESC focused update on dual antiplatelet therapy in coronary artery disease developed in collaboration with EACTS: The Task Force for dual antiplatelet therapy in coronary artery disease of the European Society of Cardiology (ESC) and of the European Association for Cardio-Thoracic Surgery (EACTS). Eur Heart J. 2018 Jan 14;39(3):213-260. doi: 10.1093/eurheartj/ehx419. No abstract available.

  PMID: 28886622 BACKGROUND

• Baber U, Zafar MU, Dangas G, Escolar G, Angiolillo DJ, Sharma SK, Kini AS, Sartori S, Joyce L, Vogel B, Farhan S, Gurbel P, Gibson CM, Fuster V, Mehran R, Badimon JJ. Ticagrelor With or Without Aspirin After PCI: The TWILIGHT Platelet Substudy. J Am Coll Cardiol. 2020 Feb 18;75(6):578-586. doi: 10.1016/j.jacc.2019.11.056.

  PMID: 32057371 BACKGROUND

• Johnson TW, Baos S, Collett L, Hutchinson JL, Nkau M, Molina M, Aungraheeta R, Reilly-Stitt C, Bowles R, Reeves BC, Rogers CA, Mundell SJ, Baumbach A, Mumford AD. Pharmacodynamic Comparison of Ticagrelor Monotherapy Versus Ticagrelor and Aspirin in Patients After Percutaneous Coronary Intervention: The TEMPLATE (Ticagrelor Monotherapy and Platelet Reactivity) Randomized Controlled Trial. J Am Heart Assoc. 2020 Dec 15;9(24):e016495. doi: 10.1161/JAHA.120.016495. Epub 2020 Dec 11.

  PMID: 33305660 BACKGROUND

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

Ticagrelor; Aspirin; Prasugrel Hydrochloride

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Thiophenes; Sulfur Compounds; Piperazines; Heterocyclic Compounds, 1-Ring

Study Officials

• Pedro A Lemos, MD, PhD

  Hospital Israelita Albert Einstein

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2023
• First Posted: March 14, 2023
• Study Start: February 6, 2023
• Primary Completion: May 30, 2025
• Study Completion: June 30, 2025
• Last Updated: April 8, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)