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

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

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.

Study Overview

• Status: Terminated
• Conditions: Angina Pectoris
• Intervention / Treatment: Drug: Clopidogrel; Drug: Prasugrel

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 Type: Interventional
• Enrollment (Actual): 795
• Phase: Phase 4

Contacts and Locations

Study Locations

• Germany
  • Munich, Germany, 80636
    • Deutsches Herzzentrum Muenchen
  • Munich, Germany
    • Klinikum Bogenhausen
  • Bad Krozingen
    • Freiburg, Bad Krozingen, Germany, 79189
      • Universitäts-Herzzentrum Freiburg, Bad Krozingen
  • Bavaria
    • Munich, Bavaria, Germany, 81377
      • Munich University Hospital
• Hungary
  • Balatonfüred, Hungary
    • Heart Center Balatonfüred and Heart and Vascular Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Prasugrel; single-dose loading with 60 mg of prasugrel pre PCI	Drug: Prasugrel; see arm description; Other Names: Efient
Active Comparator: Clopidogrel; loading with 600 mg of clopidogrel pre PCI	Drug: Clopidogrel; see arm description; Other Names: Iscover, Plavix

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Combined ischemic events	Combined outcome of all-cause death, any myocardial infarction (MI), stent thrombosis, urgent revascularization and stroke	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bleeding	Academic Research Consortium ≥2 bleeding and TIMI classification	30 days
Peri-PCI MI Type 4a	according to Third Universal Definition of MI	30 days
All-cause death	mortality	30 days
Any myocardial infarction	according to SASSICAIA protocol definition	30 days
Stent thrombosis	according to Academic Research Consortium criteria	30 days
Urgent vessel revascularization	revascularization related to symptoms	30 days
cerebro-vascular events	stroke and TIA	30 days

Collaborators and Investigators

• Sponsor: LMU Klinikum
• Investigators: Principal Investigator: Julinda Mehilli, MD, University Hospital Munich

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2015
• Primary Completion (Actual): August 1, 2018
• Study Completion (Actual): November 1, 2018

Study Registration Dates

• First Submitted: September 10, 2015
• First Submitted That Met QC Criteria: September 11, 2015
• First Posted (Estimate): September 14, 2015

Study Record Updates

• Last Update Posted (Actual): July 17, 2020
• Last Update Submitted That Met QC Criteria: July 15, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pain; Neurologic Manifestations; Chest Pain; Angina Pectoris; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Platelet Aggregation Inhibitors; Purinergic P2Y Receptor Antagonists; Purinergic P2 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Clopidogrel; Prasugrel Hydrochloride
• Other Study ID Numbers: GE IDE MucT002-14

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO