P3AMI Antiplatelet Trial
Condition: Heart Attack
MeSH terms: Myocardial Infarction
Intervention: Prasugrel; Clopidogrel; ticagrelor
Intervention MeSH terms: Clopidogrel; Ticagrelor; Prasugrel Hydrochloride
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 87.0
Sex: All
Minimum age: 18 Years
Maximum age: 100 Years
Healthy volunteers: No
Keywords: STEMI; NSTEMI; PPCI

Summary:

      Major heart attacks are caused by a numerous factors, including sudden clot formation in a
      coronary artery leading to a blockage and heart muscle death. The clots are largely made of
      sticky clotting blood cells (platelets). A patient having a major heart attack is treated
      with emergency primary percutaneous coronary intervention (PPCI) where a wire and balloon are
      used to reopen the coronary artery and a stent (a slotted metal tube) is placed to keep the
      artery open.

      Aspirin, and one of two other antiplatelet drugs (prasugrel or ticagrelor) are given prior to
      PPCI to prevent further clots formation. Both antiplatelet drugs are taken in tablet form and
      in healthy stable patients these drugs take at least 30 min to 2 hours to exert an adequate
      effect. Often PPCI procedures are performed well within this timescale. It is possible that
      having a major heart attack limits the bodies ability to absorb the drugs also.

      In this study, patients with major or minor heart attacks will be given either prasugrel or
      ticagrelor as per licensed indications and guideline recommendations. A 15 ml blood sample
      will be taken at first balloon inflation to reopen the blocked artery, then after 20 minutes,
      60 minutes, and 4 hours after taking the drugs. Each blood sample will be subjected to a
      variety of tests to determine antiplatelet drug activity.

      This study will identify which of the two agents used are working effectively during PPCI,
      given the very short timescales involved. It will also show if patients with major heart
      attacks absorb the drugs less well than patients with less severe heart attacks. In the
      future it might be that an intravenous agent will be more valuable in the setting of PPCI.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients presenting with STEMI for PCI (characterized by chest discomfort, and
             prominent STsegment elevation)

          2. Patients presenting with NSTEMI (characterized by chest discomfort, raised levels of
             myocardial enzymes and/or STsegment depression or prominent T wave inversion)

          3. Able to give verbal consent (STEMI patients pre procedure) and/or written consent
             (STEMI after procedure and NSTEMI patients prior to enrolment).

          4. Age>18 years of age

          5. Able to take Aspirin and either prasugrel or ticagrelor.

          6. Have no concurrent septic or inflammatory illness

          7. Thienopyridine naive

        Exclusion Criteria:

          1. Be unable to provide verbal and written consent

          2. Allergic to aspirin or any of the P2Y12 antagonists in the trial

          3. Have preexisting cardiogenic shock

          4. Have a concurrent septic or inflammatory disease e.g. rheumatoid arthritis, lupus,
             pneumonia.

          5. Already taking a P2Y12 inhibitor

          6. Known bleeding diathesis

          7. Patients under 75 years of age or under 60 kg or those who have had a previous
             stroke/transient ischaemic attack, will not be eligible for prasugrel but rather
             ticagrelor.

          8. Patients with a history of intracranial haemorrhage will not receive prasugrel or
             ticagrelor but rather will receive treatment with clopidogrel.