PCI-related myocardial infarction (MI type 4) or injury (I) within 48 hours (or at hospital discharge if earlier than 48 hours) of elective PCI/stent MedDRA version: 20.0 Level: PT Classification code 10028596 Term: Myocardial infarction System Organ Class: 10007541 - Cardiac disorders
Conditions
Interventions
Trade Name: Brilique
Product Name: Brilique
Product Code: AZD6140
Pharmaceutical Form: Coated tablet
INN or Proposed INN: ticagrelor
CAS Number: 274693-27-5
Current Sponsor code: AZD6140
Concentrati
Sponsors
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male or female = 18 years of age - Having at least one high-risk feature (Age > 75, Renal insufficiency (Clearance below 60ml/min calculated with Cockcroft-Gault formula), Diabetes Mellitus, Overweight (BMI >30), History of ACS (in the past 12 months) including UA/NSTEMI and STEMI, LVEF 30mm, Left main stenting, Bifurcation stenting (whatever the technique), ACC/AHA type B2 or C lesion , Stenting of venous or arterial coronary graft). - Undergoing non-emergent single or multiple sites/vessels PCI during the same procedure). - Negative troponin (hs-Tn preferably) or decreasing troponin in case of hs-Tn above the ULN and within the grey zone of the laboratory (or =65 years) yes F.1.3.1 Number of subjects for this age range 1900
Exclusion criteria
Exclusion criteria: Subjects presenting with any of the following will not be included in the study: - Women of child-bearing potential (ie, those who are not chemically or surgically sterilised or who are not post-menopause) who are not willing to use a medically accepted method of contraception that is considered reliable in the judgment of the investigator OR women who have a positive pregnancy test at randomisation OR women who are breast-feeding - Thrombolytic therapy within the previous 24 hours - Undergoing primary PCI for ongoing STEMI - Undergoing rescue PCI after failed thrombolysis - Any other elective PCI scheduled within the following 30 days after the index PCI - History of intracranial haemorrhage at any time. - Increased bleeding risk: intracranial tumor or aneurysm; recent trauma or major surgery (1.5; past or present bleeding disorder (including congenital bleeding disorders such as von Willebrand's disease or hemophilia, acquired bleeding disorders, and unexplained clinically significant bleeding disorders), thrombocytopenia (platelet count <100,000/µL) - Known severe and moderated hepatic impairment - Treatment with oral anticoagulant therapy within 72 hours prior to inclusion or current need for oral anticoagulant therapy in the next month. - Use of abciximab within the previous 7 days or, tirofiban or eptifibatide within the past 12 hours of index PCI - Prohibited treatments (see section 8.3) - Inability to give informed consent or high likelihood of being unavailable for follow-up - Participation in another clinical research protocol with other investigational agents or devices within the previous 30 days, planned use of investigational drugs or devices, or previous enrolment in this trial (routine care authorized) - Known intolerance to clopidogrel or ticagrelor - Hypersensitivity to ticagrelor or its excipients - Hypersensitivity to clopidogrel or its excipients - Patient on prasugrel or ticagrelor before the procedure
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary Efficacy Objective The purpose of this study is to demonstrate the superiority of the new P2Y12 inhibitor ticagrelor over clopidogrel on PCI-related myocardial infarction (MI type 4) or major myocardial injury (I) within 48 hours (or at hospital discharge if earlier) of elective PCI/stent. Primary Safety Objective The primary safety objective is to compare the new P2Y12 inhibitor ticagrelor over clopidogrel on major bleeding events as assessed by the BARC criteria 19 (BARC type 3 or 5) at 48 hours (or discharge if it occurs earlier). ;Secondary Objective: Secondary Efficacy Objectives are to demonstrate : - the superiority of the new P2Y12 inhibitor ticagrelor over clopidogrel on - myocardial infarction (MI) both at 48 hours (or at hospital discharge if earlier) and 30 days of elective PCI/stent. - death (any) or myocardial infarction (MI) both at 48 hours (or at hospital discharge if earlier) and 30 days of elective PCI/stent. - on death (any), MI/I, urgent revascularization or recurrent ischemia requiring catheterization at 48 hours and 30 days. - on PCI-related myocardial infarction (MI type 4) or any type of injury (major or minor) within 48 hours (or at hospital discharge if earlier) of elective PCI/stent. Secondary Safety Objectives are to assess the rates of : - major bleeding events as assessed by the BARC criteria19 (BARC type 3 or 5) at 30 days follow-up, - nuisance or minor bleeding (BARC type 1 or 2) at 48h and 30 day, - any bleeding (BARC 1, 2, 3, 4, 5) at 48h and 30 days, - stroke at 48h and 30 days.;Primary end point(s): PCI-related myocardial infarction (MI type 4) or major myocardial injury (I) within 48 hours (or at hospital discharge if earlier) of elective PCI/stent. MI-4/I at 48 hours will include the following events (according to the third universal definition of MI) The primary safety endpoint including the rate of major bleeding events (BARC 3 or 5) will be evaluated from randomization to 48 hours of elective P | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1/ Myocardial infarction (MI) both at 48 hours (hospital discharge if earlier) and 30 days of elective PCI/stent. MI will include the following events (according to the third universal definition of MI) 2/ Death (any) or myocardial infarction (MI) both at 48 hours (hospital discharge if earlier) and 30 days of elective PCI/stent. MI will include the following events (according to the third universal definition of MI18) 3/ Death (any), MI/I, urgent revascularization or recurrent ischemia requiring catheterization at 48 hours and 30 days. 4/ PCI-related myocardial infarction (MI type 4) or any type of injury (I) (major or minor) within 48 hours (or at hospital discharge if earlier) of elective PCI/stent. MI-4/I will include the following events (according to the third universal definition of MI) The secondary safety endpoints will be evaluated from randomization to 48 hours of elective PCI/stent or hospital discharge if earlier and at 30 days and will includes: o the rate of major bleeding events (BARC 3 or 5) at 30 days o Nuisance or minor bleeding (BARC type 1 or 2) o Any bleeding (BARC 1, 2, 3, 4, 5) o Any stroke.;Timepoint(s) of evaluation of this end point: 48h and 30 days | — |
Countries
Czech Republic
Contacts
Public ContactDRCI
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
Outcome results
None listed