Clinical trial NCT02548611: Comparison of Loading Strategies With Antiplatelet Drugs in Patients Undergoing Elective Coronary Intervention
Official title: Intensified Loading With Prasugrel Versus Standard Loading With Clopidogrel in Invasive-treated Patients With Biomarker-Negative Angina Pectoris
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Angina Pectoris
Lead sponsor: LMU Klinikum
Sponsor class: OTHER
First posted: 2015-09-14
Enrollment: 795
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Use of high loading doses of clopidogrel (antiplatelet drug) just before coronary interventions is associated with improved outcomes after coronary stenting. However the onset of platelet inhibition after clopidogrel loading takes 2 to 4 hours and its action if very variable. A way to overcome this limitation is loading with a more potent antiplatelet drug such as prasugrel. Therefore in the current study the investigators want to compare loading with 60 mg prasugrel (potent antiplatelet drug) and loading with clopidogrel (standard drug) in patients undergoing elective coronary intervention.

Detailed description: Patients with stable or clinically unstable (biomarker-negative) angina pectoris who are in need of coronary intervention will be randomly assigned in one of the treatment strategies - 60 mg of prasugrel or 600 mg clopidogrel just prior to percutaneous coronary intervention (PCI). After PCI all patients will receive clopidogrel 75 mg/d as per standard. The patients will be monitored throughout a 30-day time frame and ischemic and bleeding events will be recorded. The study is powered to show the superiority of single-dose 60 mg prasugrel over single-dose 600 mg clopidogrel regarding the ischemic complications at 30-day follow-up.

Eligibility criteria: Inclusion Criteria:

* Patients with biomarker negative stable or unstable angina pectoris
* Written informed consent
* In women with childbearing potential a pregnancy test is obligatory

Exclusion Criteria:

* Age \< 18 years and \>80 years
* ST-elevation MI
* Elevated cardiac biomarkers
* Subjects with known contraindications to clopidogrel treatment, which are hypersensitivity to the drug substance or any component of the product and active pathological bleeding such as peptic ulcer or intracranial hemorrhage and with known severe liver disease (Child Pugh Class C)
* Subjects with known contraindications to prasugrel treatment, which are hypersensitivity to the drug substance or any component of the product, active pathological bleeding such as peptic ulcer or intracranial hemorrhage and a history of prior transient ischemic attack (TIA) or stroke and with known severe liver disease (Child Pugh Class C)
* Chronic therapy on potent P2Y12 receptor inhibitors (ticagrelor, prasugrel)
* Pre-treatment with a loading dose of either clopidogrel, prasugrel or ticagrelor
* Simultaneous participation in another clinical trial that involves the administration of an investigational medicinal drug within 30 days prior to the start of this clinical trial
* Major surgeries in the last 6 weeks and planned surgeries within the next 6 weeks (per decision of the treating physician)
* Active bleeding
* Known or persistent abuse of medication, drugs or alcohol
* Current or planned pregnancy or nursing women, women 90 days after childbirth. Females of childbearing potential, who do not use and are not willing to use medically reliable methods of contraception for the entire study duration (such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices) unless they are surgically sterilized / hysterectomized or there are any other criteria considered sufficiently reliable by the investigator in individual cases

Primary outcomes:
measure: Combined ischemic events
timeFrame: 30 days
Secondary outcomes:
measure: Bleeding
timeFrame: 30 days
measure: Peri-PCI MI Type 4a
timeFrame: 30 days
measure: All-cause death
timeFrame: 30 days
measure: Any myocardial infarction
timeFrame: 30 days
measure: Stent thrombosis
timeFrame: 30 days
measure: Urgent vessel revascularization
timeFrame: 30 days
measure: cerebro-vascular events
timeFrame: 30 days
Other outcomes:
Locations:
city: Freiburg
country: Germany
facility: Universitäts-Herzzentrum Freiburg, Bad Krozingen
state: Bad Krozingen
city: Munich
country: Germany
facility: Munich University Hospital
state: Bavaria
city: Munich
country: Germany
facility: Deutsches Herzzentrum Muenchen
city: Munich
country: Germany
facility: Klinikum Bogenhausen
city: Balatonfüred
country: Hungary
facility: Heart Center Balatonfüred and Heart and Vascular Center
Study officials:
affiliation: University Hospital Munich
name: Julinda Mehilli, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mehilli J, Baquet M, Hochholzer W, Mayer K, Tesche C, Aradi D, Xu Y, Thienel M, Gschwendtner S, Zadrozny M, Jochheim D, Sibbing D, Schupke S, Mansmann U, Hoffmann E, Kastrati A, Neumann FJ, Massberg S. Randomized Comparison of Intensified and Standard P2Y12-Receptor-Inhibition Before Elective Percutaneous Coronary Intervention: The SASSICAIA Trial. Circ Cardiovasc Interv. 2020 Jun;13(6):e008649. doi: 10.1161/CIRCINTERVENTIONS.119.008649. Epub 2020 Jun 12.