Prasugrel and Ticagrelor in ST-segment Elevation Myocardial Infarction

ST-Segment Elevation Myocardial Infarction Clinical Trial

Official title:

Comparison of Prasugrel and Ticagrelor Antiplatelet Effects in Korean Patients Presenting With ST-segment Elevation Myocardial Infarction

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02075125
• Other study ID #: PANTASTIC
• Status: Terminated
• Phase: Phase 3
• First received: February 20, 2014
• Last updated: February 3, 2016
• Start date: January 2014
• Est. completion date: April 2015

Study information

• Verified date: February 2016
• Source: Dong-A University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

To compare efficacy and safety of prasugrel and ticagrelor in patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention.

Description:

Prasugrel and ticagrelor are recommended in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI). Both prasugrel and ticagrelor show more rapid and potent antiplatelet effect compared with clopidogrel. However, previous report comparing the efficacy and safety of prasugrel and ticagrelor in patients with STEMI of East Asian ethnicity is lacking. Therefore, the aim of this study is to compare the antiplatelet efficacy and safety using laboratory platelet function tests and clinical outcomes in patients with STEMI treated with either prasugrel or ticagrelor.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 39
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients with ST-segment elevation myocardial infarction

• Undergoing primary percutaneous coronary intervention

• Aged between 20 and 80 years

Exclusion Criteria:

• Previous administration of any antagonist of the platelet adenosine diphosphate (ADP) P2Y12 receptor (clopidogrel, prasugrel or ticagrelor)

• History of stroke or transient ischemic attack

• Previous gastrointestinal bleeding within 6 months, bleeding diathesis, platelet count < 100,000/mm3 or hemoglobin < 10 g/dl

• Chronic oral anticoagulation treatment

• Contraindication to the antiplatelet treatment

• Severe renal insufficiency (serum creatine>2.5 mg/dl)

• Severe hepatic dysfunction (serum liver enzyme or bilirubin>3 times normal limit)

• Sever chronic obstructive pulmonary disease (COPD) or bradycardia

• Body weight < 50 kg

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• ST-Segment Elevation Myocardial Infarction

Intervention

Drug:
• Prasugrel 60 mg
Patient administer prasugrel 60 mg as loading dose followed by 10 mg/day as maintenance dose.
• Ticagrelor 180 mg
Patients administer ticagrelor 180 mg as loading dose followed by 90 mg bid as maintenance dose.

Locations

Country	Name	City	State
Korea, Republic of	DongA University Hospital	Busan

Sponsors (1)

Lead Sponsor	Collaborator
Dong-A University

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (2)

Alexopoulos D, Xanthopoulou I, Gkizas V, Kassimis G, Theodoropoulos KC, Makris G, Koutsogiannis N, Damelou A, Tsigkas G, Davlouros P, Hahalis G. Randomized assessment of ticagrelor versus prasugrel antiplatelet effects in patients with ST-segment-elevation myocardial infarction. Circ Cardiovasc Interv. 2012 Dec;5(6):797-804. doi: 10.1161/CIRCINTERVENTIONS.112.972323. Epub 2012 Nov 20. — View Citation

Parodi G, Valenti R, Bellandi B, Migliorini A, Marcucci R, Comito V, Carrabba N, Santini A, Gensini GF, Abbate R, Antoniucci D. Comparison of prasugrel and ticagrelor loading doses in ST-segment elevation myocardial infarction patients: RAPID (Rapid Activity of Platelet Inhibitor Drugs) primary PCI study. J Am Coll Cardiol. 2013 Apr 16;61(15):1601-6. doi: 10.1016/j.jacc.2013.01.024. Epub 2013 Mar 22. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With High Platelet Reactivity	Platelet reactivity were measured by VerifyNow (Accumetrics, San Diego, California, USA), and vasodilator-stimulated phosphoprotein (VASP) phosphorylation P2Y12 assay (BioCytex, Marseille, France) with FACSCalibur flow cytometer (BD Biosciences, San Jose, California, USA) using. Measurement time gap +/- 12 hours were allowed. High platelet reactivity (HPR) is defined as the result of P2Y12 reaction units (PRU) >235 and platelet reactivity index (PRI) >50%.	48 hours after loading dose of study drug	No
Secondary	Major Adverse Cardiac and Cerebrovascular Events	Any major adverse cardiac and cerebrovascular event including (death, myocardial infarction, or revascularization and stroke) until day 30.	30 days	Yes
Secondary	Bleeding Event	Any event related to bleeding including access site bleeding and peri-procedural bleeding based on Bleeding Academic Research Consortium (BARC) criteria.	30 days	Yes
Secondary	Adverse Drug Reaction	Any adverse reaction related to study drug until 30 days after percutaneous coronary intervention.	30 days	Yes
Secondary	Pre-procedure P2Y12 Reaction Units (PRU)	Platelet reactivity was measured using VerifyNow (Accumetrics, San Diego, California, USA). Platelet reactivity values were presented as P2Y12 reaction units (PRU).	Baseline	No
Secondary	Number of Participants With Low Platelet Reactivity	Platelet reactivity were measured using VerifyNow (Accumetrics, San Diego, California, USA), and vasodilator-stimulated phosphoprotein (VASP) phosphorylation P2Y12 assay (BioCytex, Marseille, France) with FACSCalibur flow cytometer (BD Biosciences, San Jose, California, USA) using. Measurement time gap +/- 12 hours were allowed. Low platelet reactivity (LPR) is defined as the result of P2Y12 reaction units (PRU) <85 and platelet reactivity index (PRI)<16%. The PRU value for LPR, 18 patients were in prasugrel groups and 19 patients in ticagrelor groups, regarding the PRI value for LPR, 16 patients were in each groups.	48 hours after loading dose of study drug	No
Secondary	Pre-procedure Platelet Reactivity Index (PRI)	Platelet reactivity was measured using vasodilator-stimulated phosphoprotein (VASP) phosphorylation P2Y12 assay. Platelet reactivity values were presented as platelet reactivity index (PRI).	Baseline	No