Status:
COMPLETED
Ticagrelor Administered as Standard Tablet or Orodispersible Formulation
Lead Sponsor:
Azienda Ospedaliero Universitaria di Sassari
Collaborating Sponsors:
AstraZeneca
Conditions:
ST Elevation Myocardial Infarction
NSTEMI - Non-ST Segment Elevation MI
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Randomized clinical study evaluating superiority in platelet inhibition after administration of Ticagrelor 180 mg loading dose as an orodispersible formulation versus traditional coated tablets in pat...
Detailed Description
Primary percutaneous coronary intervention (PPCI) is the preferred reperfusion strategy for patients with acute ST-segment elevation myocardial infarction (STEMI). Additional antithrombotic therapy pr...
Eligibility Criteria
Inclusion
- Patients presenting within 12 hours from the onset of symptoms with STEMI or very high-risk NSTEMI referred for immediate (\< 2 hours) angiography. Very high-risk NSTEMI patients include patients with haemodynamic instability or cardiogenic shock, heart failure, life-threatening arrhythmias or resuscitated cardiac arrest, intermittent ST-segment elevation, or ongoing chest pain.
- Informed, written consent
- Male or female patients, aged ≥ 18 years old
Exclusion
- Age \< 18 years
- Active bleeding; bleeding diathesis; coagulopathy
- History of gastrointestinal or genitourinary bleeding \<2 months
- Major surgery in the last 6 weeks
- History of intracranial bleeding or structural abnormalities
- Suspected aortic dissection
- Administration in the week before the index event of clopidogrel, ticlopidine, prasugrel, ticagrelor, thrombolytics, bivalirudin, low-molecular weight heparin or fondaparinux.
- Concomitant oral or IV therapy with strong CYP3A inhibitors or strong CYP3A inducers, CYP3A with narrow therapeutic window
- Known relevant hematological deviations: Hb \<10 g/dl, Thromb. \<100x10\^9/l
- Use of warfarin or new oral anticoagulant derivatives within the last 7 days
- Known severe liver disease, severe renal failure
- Allergy or hypersensitivity to ticagrelor or any of the excipients.
- Pregnancy or lactation
Key Trial Info
Start Date :
June 27 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2020
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT03822377
Start Date
June 27 2019
End Date
August 31 2020
Last Update
September 8 2021
Active Locations (1)
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1
Cardiologia Clinica e Interventistica - AOU Sassari
Sassari, Italy, 07100