Randomized Comparison of Cangrelor, Tirofiban and Prasugrel in Patients With STEMI Referred for Primary PCI.

• Status: Completed
• Trial end date: 2019-12-27
• Target enrollment: 0
• Participant gender: All

Summary

Primary percutaneous coronary intervention (PCI) is the main reperfusion therapy in patients with ST-elevation myocardial infarction (STEMI). The optimal platelet inhibition at the time of PCI is fundamental, however, the comparative speed of action of cangrelor as opposed to tirofiban and to chewed or integer loading dose of prasugrel is unknown.

The purpose of this trial is to assess the inhibition of platelet aggregation with different regimens on platelet inhibition (tirofiban bolus+infusion, cangrelor bolus+infusion, prasugrel chewed loading dose, prasugrel integer loading dose) in the early phase of primary PCI.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital Inselspital, Berne
• Treatments: Cangrelor; Prasugrel Hydrochloride; Tirofiban

Criteria

Inclusion Criteria:

• Age greater than 18 years old

• ST-segment elevation myocardial infarction

• Referred for primary PCI either within 12 h of symptom onset or between 12 and 24 h after onset with evidence of continuing ischemia

Exclusion Criteria:

• Unconsciousness

• Other conditions that make the patient incapable receiving integer loading dose of prasugrel

• Any contraindication and/or known hypersensitivity or allergy to aspirin, prasugrel, intravenous unfractionated heparin, cangrelor, tirofiban

• Any contraindication to primary PCI

• Administration of glycoprotein IIb/IIIa inhibitors (GPI) or P2Y12-inhibitors or cangrelor < 7 days

• Chronic dialysis

• Recent (< 15 days) or current major bleeding

• Recent (< 15 days) major surgery

• Administration of fibrinolytics < 30 days

• Current use or indication to oral anticoagulant

• Previous stroke or transient ischemic attack (TIA)

• Inability to follow the procedures of the study (language problems, psychological disorders, dementia) or comorbidities associated with less than 6 months survival (active malignancies drug or alcohol abuse, etc.)

• Women who are pregnant or breast feeding or with potential to become pregnant during the course of the study (age < 55 years and last menstruation within the last 12 months) and did not undergo tubal ligation, ovariectomy or hysterectomy

• Participation in another study with investigational drug within the 30 days preceding and during the present study

• Enrolment of the investigator, his/her family members, employees and other dependent persons