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Platelet Sub-study of the Neomindset Trial

Primary Purpose

Acute Coronary Syndrome

Status
Recruiting
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Dual antiplatelet therapy: Acetylsalicylic acid + ticagrelor OR Acetylsalicylic acid + prasugrel
Monotherapy: Ticagrelor alone OR Prasugrel alone
Sponsored by
Hospital Israelita Albert Einstein
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Acute Coronary Syndrome focused on measuring acute coronary syndrome, antithrombotic therapy, dual antiplatelet therapy, monotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital Israelita Albert EinsteinRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Acetylsalicylic acid + ticagrelor OR Acetylsalicylic acid + prasugrel

Ticagrelor alone or prasugrel alone

Arm Description

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)

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)

Outcomes

Primary Outcome Measures

Platelet function using PFA-100
Platelet function using PFA-100

Secondary Outcome Measures

Platelet function using CHRONO-LOG
Platelet function using CHRONO-LOG
Platelet function using Rotem-platelet
Platelet function using Rotem-platelet
Coagulation test using thromboelastogram
Coagulation test using thromboelastogram

Full Information

First Posted
February 15, 2023
Last Updated
March 2, 2023
Sponsor
Hospital Israelita Albert Einstein
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1. Study Identification

Unique Protocol Identification Number
NCT05767723
Brief Title
Platelet Sub-study of the Neomindset Trial
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 6, 2023 (Actual)
Primary Completion Date
February 6, 2024 (Anticipated)
Study Completion Date
March 6, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital Israelita Albert Einstein

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome
Keywords
acute coronary syndrome, antithrombotic therapy, dual antiplatelet therapy, monotherapy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Acetylsalicylic acid + ticagrelor OR Acetylsalicylic acid + prasugrel
Arm Type
Active Comparator
Arm Description
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)
Arm Title
Ticagrelor alone or prasugrel alone
Arm Type
Experimental
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
Dual antiplatelet therapy: Acetylsalicylic acid + ticagrelor OR Acetylsalicylic acid + prasugrel
Intervention Description
Acetylsalicylic acid (100 mg/day) + ticagrelor (90 mg twice daily) Or Acetylsalicylic acid (100 mg/day) + prasugrel (10 mg once daily)
Intervention Type
Drug
Intervention Name(s)
Monotherapy: Ticagrelor alone OR Prasugrel alone
Intervention Description
Ticagrelor alone (90 mg twice daily) OR Prasugrel alone (10 mg once daily)
Primary Outcome Measure Information:
Title
Platelet function using PFA-100
Description
Platelet function using PFA-100
Time Frame
30 days of treatment
Secondary Outcome Measure Information:
Title
Platelet function using CHRONO-LOG
Description
Platelet function using CHRONO-LOG
Time Frame
30 days of treatment
Title
Platelet function using Rotem-platelet
Description
Platelet function using Rotem-platelet
Time Frame
30 days of treatment
Title
Coagulation test using thromboelastogram
Description
Coagulation test using thromboelastogram
Time Frame
30 days of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pedro A Lemos, MD, PhD
Phone
+55 (11) 98317-5000
Email
pedro.lemos@einstein.br
First Name & Middle Initial & Last Name or Official Title & Degree
Thiago P Oliveira, MD
Phone
+55 (11) 995073003
Email
thiago.poliveira@einstein.br
Facility Information:
Facility Name
Hospital Israelita Albert Einstein
City
São Paulo
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thiago P Oliveira, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28886622
Citation
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.
Results Reference
background
PubMed Identifier
32057371
Citation
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.
Results Reference
background
PubMed Identifier
33305660
Citation
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.
Results Reference
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Platelet Sub-study of the Neomindset Trial

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