SASSICAIA: Comparison of Loading Strategies With Antiplatelet Drugs in Patients Undergoing Elective Coronary Intervention
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Prasugrel single-dose loading with 60 mg of prasugrel pre PCI |
Drug: Prasugrel
see arm description
Other Names:
|
| Active Comparator: Clopidogrel loading with 600 mg of clopidogrel pre PCI |
Drug: Clopidogrel
see arm description
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Combined ischemic events [30 days]
Combined outcome of all-cause death, any myocardial infarction (MI), stent thrombosis, urgent revascularization and stroke
Secondary Outcome Measures
- Bleeding [30 days]
Academic Research Consortium ≥2 bleeding and TIMI classification
- Peri-PCI MI Type 4a [30 days]
according to Third Universal Definition of MI
- All-cause death [30 days]
mortality
- Any myocardial infarction [30 days]
according to SASSICAIA protocol definition
- Stent thrombosis [30 days]
according to Academic Research Consortium criteria
- Urgent vessel revascularization [30 days]
revascularization related to symptoms
- cerebro-vascular events [30 days]
stroke and TIA
Eligibility Criteria
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)
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Universitäts-Herzzentrum Freiburg, Bad Krozingen | Freiburg | Bad Krozingen | Germany | 79189 |
| 2 | Munich University Hospital | Munich | Bavaria | Germany | 81377 |
| 3 | Deutsches Herzzentrum Muenchen | Munich | Germany | 80636 | |
| 4 | Klinikum Bogenhausen | Munich | Germany | ||
| 5 | Heart Center Balatonfüred and Heart and Vascular Center | Balatonfüred | Hungary |
Sponsors and Collaborators
- LMU Klinikum
Investigators
- Principal Investigator: Julinda Mehilli, MD, University Hospital Munich
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- GE IDE MucT002-14