Recruiting PHASE4 Myocardial Infarction

New treatment option for Myocardial Infarction

Official title Reduced Antithrombotic Strategy for High Bleeding Risk Patients With Myocardial Infarction

ClinicalTrials.gov ID: NCT05262803

What this study is testing

What is CYP2C19*2/*3?

CYP2C19*2/*3 is an investigational medicine, being studied as a potential treatment for myocardial infarction.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
Rationale: Heart attacks are a major cause of death and result from coronary blood clots that require acute coronary intervention and antithrombotic drugs to restore blood flow and prevent new heart attacks. Over time, more potent antithrombotic drugs have been introduced like prasugrel and ticagrelor.
  • Phase 4: studies an already-approved treatment

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 and older

You may be able to join if

  • MI caused by atherothrombotic CAD (Type 1 MI) according to "The Fourth Universal Definition of MI", which has been treated with PCI with contemporary...
  • symptoms indicating acute myocardial ischemia
  • new ischemic changes on the electrocardiogram
  • development of pathological Q-waves
  • imaging evidence of new loss of viable myocardium or new regional wall motion abnormality in a pattern consistent with an ischemic etiology

You likely can't join if

  • Contraindications including allergies to ASA or P2Y12 inhibitors
  • Indication for oral anticoagulation
  • Previous stent thrombosis
  • Life expectancy \<1 year
  • Resuscitated cardiac arrest with Glasgow Coma Scale \<8 and/or need of intubation
  • Prior intracranial hemorrhage
See the full eligibility criteria
Who can join
  • MI caused by atherothrombotic CAD (Type 1 MI) according to "The Fourth Universal Definition of MI", which has been treated with PCI with contemporary drug-eluting stents. This definition of type 1 MI requires the...
  • symptoms indicating acute myocardial ischemia
  • new ischemic changes on the electrocardiogram
  • development of pathological Q-waves
  • imaging evidence of new loss of viable myocardium or new regional wall motion abnormality in a pattern consistent with an ischemic etiology
  • visible coronary thrombus by angiography
  • PRECISE-DAPT score ≥25
  • Age ≥18 years
What rules you out
  • Contraindications including allergies to ASA or P2Y12 inhibitors
  • Indication for oral anticoagulation
  • Previous stent thrombosis
  • Life expectancy \<1 year
  • Resuscitated cardiac arrest with Glasgow Coma Scale \<8 and/or need of intubation
  • Prior intracranial hemorrhage
  • Active bleeding (BARC ≥2) at randomization
  • Women who are pregnant, have given birth recently (within the past 90 days), are lactating, or are fertile without contraception
  • Hypertensive crisis (systolic blood pressure \>180 mmHg and/or diastolic blood pressure \>120 mmHg)
  • Unable to understand and follow study-related instructions or to comply with study protocol

The study team makes the final eligibility decision.

Where it's taking place

  • Aalborg, Denmark
  • Copenhagen, Denmark
  • Hellerup, Denmark
  • Odense, Denmark
  • Roskilde, Denmark
  • Skejby, Denmark

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Aalborg, Denmark; Copenhagen, Denmark; Hellerup, Denmark; Odense, Denmark; Roskilde, Denmark; Skejby, Denmark. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.