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

• Status: Terminated
• Trial end date: 2018-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Klinikum der Universitaet Muenchen; LMU Klinikum
• Treatments: Clopidogrel; Prasugrel Hydrochloride; Ticlopidine

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