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

Angina Pectoris Clinical Trial

— SASSICAIA  

Official title:

Intensified Loading With Prasugrel Versus Standard Loading With Clopidogrel in Invasive-treated Patients With Biomarker-Negative Angina Pectoris

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02548611
• Other study ID #: GE IDE MucT002-14
• Status: Terminated
• Phase: Phase 4
• Start date: September 2015
• Est. completion date: November 2018

Study information

• Verified date: July 2020
• Source: Klinikum der Universitaet Muenchen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 795
• Est. completion date: November 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Angina Pectoris

Intervention

Drug:
• Prasugrel
see arm description
• Clopidogrel
see arm description

Locations

Country	Name	City	State
Germany	Universitäts-Herzzentrum Freiburg, Bad Krozingen	Freiburg	Bad Krozingen
Germany	Deutsches Herzzentrum Muenchen	Munich
Germany	Klinikum Bogenhausen	Munich
Germany	Munich University Hospital	Munich	Bavaria
Hungary	Heart Center Balatonfüred and Heart and Vascular Center	Balatonfüred

Sponsors (1)

Lead Sponsor	Collaborator
Klinikum der Universitaet Muenchen

Countries where clinical trial is conducted

Germany,  Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Combined ischemic events	Combined outcome of all-cause death, any myocardial infarction (MI), stent thrombosis, urgent revascularization and stroke	30 days
Secondary	Bleeding	Academic Research Consortium =2 bleeding and TIMI classification	30 days
Secondary	Peri-PCI MI Type 4a	according to Third Universal Definition of MI	30 days
Secondary	All-cause death	mortality	30 days
Secondary	Any myocardial infarction	according to SASSICAIA protocol definition	30 days
Secondary	Stent thrombosis	according to Academic Research Consortium criteria	30 days
Secondary	Urgent vessel revascularization	revascularization related to symptoms	30 days
Secondary	cerebro-vascular events	stroke and TIA	30 days

External Links

•   Study result publication