Comparison of Loading Strategies With Antiplatelet Drugs in Patients Undergoing Elective Coronary Intervention (SASSICAIA)

LMU Klinikum

Status and phase

Terminated

Phase 4

Conditions

Angina Pectoris

Treatments

Drug: Clopidogrel

Drug: Prasugrel

Study type

Interventional

Funder types

Other

Identifiers

NCT02548611

GE IDE MucT002-14

Details and patient eligibility

About

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.

Full 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.

Enrollment

795 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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