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NCT05767723Active, not recruitingPhase 4

Platelet Sub-study of the Neomindset Trial

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

Source: ClinicalTrials.gov · Last updated 8 Apr 2025

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
48 (estimated)
First submitted
15 Feb 2023
Start date
6 Feb 2023
Primary completion date
30 May 2025
Lead sponsor
Hospital Israelita Albert Einstein
NCT number
NCT05767723

What you commit to

  • Study type: Interventional · Phase 4
  • Planned participants: 48
  • From 6 Feb 2023 to the primary completion date, 30 May 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Fibrinolytic therapy \< 24 hour before randomization;
  • Prior intracranial hemorrhage;
  • Impossibility of being treated with dual antiplatelet therapy for 12 months, based on investigator judgement.

Other illness

  • Acute coronary syndrome on index admission treated in a conservative way or by unsuccessful percutaneous intervention or surgically;
  • Chronic bleeding diathesis;
  • Active or recent major bleeding (in-hospital);
  • 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;
  • 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;
  • Any significant medical condition that, in the investigator's opinion, could interfere with the ideal participation of the subject in the study;

Lab values

  • 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);

Other

  • Presence of residual lesions which are likely to require future treatment in the next 12 months;
  • Need of oral anticoagulation with warfarin or new anticoagulants;
  • Ischemic cerebrovascular accident \< 30 days;
  • Presence of brain arteriovenous malformation;
  • Subject with life expectation lower than 1 year;
  • Participation in other study in the past 12 months, unless a direct benefit to the subject can be expected.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Hospital Israelita Albert Einstein
Coordinator of this site? Confirm its status
São PauloBrazilUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.