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

NCT ID: NCT02548611

Last Updated: 2020-07-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 795 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2018-11-30

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.

Conditions

Angina Pectoris

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Prasugrel

single-dose loading with 60 mg of prasugrel pre PCI

Group Type: EXPERIMENTAL

Prasugrel

Intervention Type: DRUG

see arm description

Clopidogrel

loading with 600 mg of clopidogrel pre PCI

Group Type: ACTIVE_COMPARATOR

Clopidogrel

Intervention Type: DRUG

see arm description

Interventions

Prasugrel

see arm description

Intervention Type: DRUG

Clopidogrel

see arm description

Intervention Type: DRUG

Other Intervention Names

Efient; Iscover, Plavix

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

LMU Klinikum

OTHER

Sponsor Role: lead

Responsible Party

Prof. Dr. Julinda Mehilli

Prof. Dr. med.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Julinda Mehilli, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Munich

Locations

Universitäts-Herzzentrum Freiburg, Bad Krozingen

Freiburg im Breisgau, Bad Krozingen, Germany

Munich University Hospital

Munich, Bavaria, Germany

Deutsches Herzzentrum Muenchen

Munich, , Germany

Klinikum Bogenhausen

Munich, , Germany

Heart Center Balatonfüred and Heart and Vascular Center

Balatonfüred, , Hungary

Countries

Germany; Hungary

References

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.

Reference Type: DERIVED

PMID: 32527192 (View on PubMed)

Other Identifiers

GE IDE MucT002-14

Identifier Type: -

Identifier Source: org_study_id