Phase 3 N=130 Randomized Single-blind Treatment

Ticagrelor Administered as Standard Tablet or Orodispersible Formulation

ST Elevation Myocardial Infarction · NSTEMI - Non-ST Segment Elevation MI

Bottom Line

View on ClinicalTrials.gov: NCT03822377 ↗

Enrolled (actual)

130

Serious AEs

0.8%

Results posted

Sep 2021

Primary outcome: Primary: Evaluation of Platelet Inhibition — 94; 141 P2Y12 Reaction Units (PRU)

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Ticagrelor orodispersible tablets (Drug); Ticagrelor standard tablets (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Azienda Ospedaliero Universitaria di Sassari
Primary completion: Aug 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Evaluation of Platelet Inhibition	94; 141	—
SECONDARY Percent of Patients With Insufficient Antiaggregation	51; 53	—
SECONDARY Number of Participants With Residual Platelet Reactivity at Various Timepoints	42; 9	—
SECONDARY Number of Participants With Clinically Relevant Bleeding Events	0; 4	—

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 patients admitted for ST elevation myocardial infarction or very high-risk non-ST elevation myocardial infarction.

Eligibility Criteria

Inclusion Criteria

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 Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03822377). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.