Health Trials

Dual Antiplatelet Therapy Strategies After Acute Myocardial Infarction Undergoing PCI: Prasugrel vs Ticagrelor & 12 Months vs 1-3 Months

ConditionMyocardial Infarction (MI)
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstituto de Investigación Sanitaria de la Fundación Jiménez Díaz

About this trial

This study is testing different blood-thinning treatment strategies for people who have had a heart attack and were successfully treated with a coronary stent procedure (PCI). All strategies tested are already approved for this condition and used inversally. This study will define which of the approved strategies is the best one.

After PCI, patients usually receive two antiplatelet medicines for up to 12 months to help prevent another heart attack or stroke, but this treatment can also increase bleeding risk. This study will compare a shorter course of dual antiplatelet therapy followed by one antiplatelet medicine alone versus the standard 12-month course. In addition, the study will compare two commonly used antiplatelet drugs, prasugrel and ticagrelor. The goal is to find out which strategy best prevents death, heart attack, or stroke while minimizing serious bleeding.

This study is not testing any new intervention, rather comparing approved drugs and approved durations of use.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

≥18 years old

Admitted because of an acute MI (either STEMI or NSTEMI).

Invasive management during index admission with successful PCI.

Able to consent.

Disqualifiers

Indication for oral anticoagulation therapy.

Intolerance, contraindication or known allergy to either aspirin, prasugrel or ticagrelor.

Prior history of ischaemic or haemorrhagic stroke or transient ischaemic attack.

Patients with active bleeding or known bleeding disorders.

Trial design

Design model

Factorial

Treatments tested in this trial

  • Prasugrel

    Drug

    Prasugrel during 12 months

  • Ticagrelor

    Drug

    Ticagrelor plus aspirin

Treatment groups

8,100 Participants
are divided into 4 treatment groups
Group A: Prasugrel 12 months DAPTActive comparator 1 intervention
Group B: Prasugrel abbreviated DAPTExperimental treatment 1 intervention
Group C: Ticagrelor 12 months DAPTExperimental treatment 1 intervention
Group D: Ticagrelor abbreviated DAPTExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

ischemic events

incidence of the composite of "all-cause death, reinfarction or stroke"

Time frame
12 months

Secondary outcomes

1

All-cause death

incidence of death from any cause

Time frame
12 months
2

Reinfarction

incidence of non fatal reinfarction

Time frame
12 months
3

stroke

incidence of stroke (ischemic or hemorrhagic)

Time frame
12 months
4

cardiovascular death

incidence of detah from cardiovascular cause

Time frame
12 months

Other outcomes

1

Safety outcome (bleeding)

incidence of major bleeding (defined as BARC 3-5)

Time frame
12 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Lead sponsor

Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III

Collaborator

Source ClinicalTrials.gov
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