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

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ClinicalTrials.gov Identifier: NCT02548611
Recruitment Status : Terminated (Due to low recruitment)
First Posted : September 14, 2015
Last Update Posted : July 17, 2020
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. Julinda Mehilli, LMU Klinikum

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
Angina Pectoris Drug: Prasugrel Drug: Clopidogrel 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 795 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intensified Loading With Prasugrel Versus Standard Loading With Clopidogrel in Invasive-treated Patients With Biomarker-Negative Angina Pectoris
Actual Study Start Date : September 2015
Actual Primary Completion Date : August 2018
Actual Study Completion Date : November 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angina

Arm Intervention/treatment
Experimental: Prasugrel
single-dose loading with 60 mg of prasugrel pre PCI
Drug: Prasugrel
see arm description
Other Name: Efient

Active Comparator: Clopidogrel
loading with 600 mg of clopidogrel pre PCI
Drug: Clopidogrel
see arm description
Other Name: Iscover, Plavix




Primary Outcome Measures :
  1. Combined ischemic events [ Time Frame: 30 days ]
    Combined outcome of all-cause death, any myocardial infarction (MI), stent thrombosis, urgent revascularization and stroke


Secondary Outcome Measures :
  1. Bleeding [ Time Frame: 30 days ]
    Academic Research Consortium ≥2 bleeding and TIMI classification

  2. Peri-PCI MI Type 4a [ Time Frame: 30 days ]
    according to Third Universal Definition of MI

  3. All-cause death [ Time Frame: 30 days ]
    mortality

  4. Any myocardial infarction [ Time Frame: 30 days ]
    according to SASSICAIA protocol definition

  5. Stent thrombosis [ Time Frame: 30 days ]
    according to Academic Research Consortium criteria

  6. Urgent vessel revascularization [ Time Frame: 30 days ]
    revascularization related to symptoms

  7. cerebro-vascular events [ Time Frame: 30 days ]
    stroke and TIA



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02548611


Locations
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Germany
Universitäts-Herzzentrum Freiburg, Bad Krozingen
Freiburg, Bad Krozingen, Germany, 79189
Munich University Hospital
Munich, Bavaria, Germany, 81377
Deutsches Herzzentrum Muenchen
Munich, Germany, 80636
Klinikum Bogenhausen
Munich, Germany
Hungary
Heart Center Balatonfüred and Heart and Vascular Center
Balatonfüred, Hungary
Sponsors and Collaborators
LMU Klinikum
Investigators
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Principal Investigator: Julinda Mehilli, MD University Hospital Munich
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Prof. Dr. Julinda Mehilli, Prof. Dr. med., LMU Klinikum
ClinicalTrials.gov Identifier: NCT02548611    
Other Study ID Numbers: GE IDE MucT002-14
First Posted: September 14, 2015    Key Record Dates
Last Update Posted: July 17, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Angina Pectoris
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Neurologic Manifestations
Clopidogrel
Prasugrel Hydrochloride
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs