Phase
Condition
Myocardial Ischemia
Coronary Artery Disease
Circulation Disorders
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 < 40%and/or prior episode of heart failure, Multivessel disease (2 or 3 V), Multiple stentsneeded defined as i) more than one stent implanted in one vessel or ii) more than 2stents in 2 or more vessels, or iii) total stent length envisioned > 30mm, Left mainstenting, 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 sameprocedure)
Negative troponin before enrolment (according to local measurement - hsTn preferably)
Informed consent obtained in writing at enrolment into the study
Exclusion
Exclusion Criteria:
Women of child-bearing potential (ie, those who are not chemically or surgicallysterilised or who are not post-menopause) who are not willing to use a medicallyaccepted method of contraception that is considered reliable in the judgment of theinvestigator OR women who have a positive pregnancy test at randomisation OR women whoare 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 majorsurgery (< 1 month) (including bypass surgery), active gastrointestinal, activebleeding
Uncontrolled arterial hypertension (defined as a systolic BP ≥180 mmHg and/ordiastolic BP ≥100 mmHg)
Recent (<48 hours) or planned spinal/epidural anesthesia or puncture
Impaired haemostasis such as known International Normalized Ratio (INR) >1.5; past orpresent bleeding disorder (including congenital bleeding disorders such as vonWillebrand's disease or hemophilia, acquired bleeding disorders, and unexplainedclinically 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 orcurrent need for oral anticoagulant therapy in the next month.
Use of abciximab within the previous 7 days or, tirofiban or eptifibatide within thepast 12 hours of index PCI
Prohibited treatments (see section 8.3)
Inability to give informed consent or high likelihood of being unavailable forfollow-up
Participation in another clinical research protocol with other investigational agentsor devices within the previous 30 days, planned use of investigational drugs ordevices, 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
Study Design
Connect with a study center
Institut de Cardiologie - USIC - Hôpital Pitié-Salpêtrière
Paris, 75013
FranceSite Not Available
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