Assessment of Loading with the P2Y12 inhibitor Ticagrelor or clopidogrel to Halt ischemic Events in patients Undergoing elective coronary Stenting: the ALPHEUS study.

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 1900

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 stents needed defined as i) more than one stent implanted in one vessel or ii) more than 2 stents in 2 or more vessels, or iii) total stent length envisioned > 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 <3XULN if the grey zone is not defined) before enrolment according to local measurement, during hospitalization for coronary angiogram or PCI.
-Informed consent obtained in writing at enrolment into the study

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1900
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1900

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 month) (including bypass surgery), active gastrointestinal, active bleeding
-Uncontrolled arterial hypertension (defined as a systolic BP = 180 mmHg and/or diastolic 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 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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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