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

Primary Purpose

Angina Pectoris

Status

Terminated

Phase

Phase 4

Locations

International

Study Type

Interventional

Intervention

Prasugrel

Clopidogrel

About this trial

This is an interventional treatment trial for Angina Pectoris

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Universitäts-Herzzentrum Freiburg, Bad Krozingen
Munich University Hospital
Deutsches Herzzentrum Muenchen
Klinikum Bogenhausen
Heart Center Balatonfüred and Heart and Vascular Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Prasugrel

Clopidogrel

Arm Description

single-dose loading with 60 mg of prasugrel pre PCI

loading with 600 mg of clopidogrel pre PCI

Outcomes

Primary Outcome Measures

Combined ischemic events

Combined outcome of all-cause death, any myocardial infarction (MI), stent thrombosis, urgent revascularization and stroke

Secondary Outcome Measures

Bleeding

Academic Research Consortium ≥2 bleeding and TIMI classification

Peri-PCI MI Type 4a

according to Third Universal Definition of MI

All-cause death

mortality

Any myocardial infarction

according to SASSICAIA protocol definition

Stent thrombosis

according to Academic Research Consortium criteria

Urgent vessel revascularization

revascularization related to symptoms

cerebro-vascular events

stroke and TIA

Full Information

NCT ID

NCT02548611

First Posted

September 10, 2015

Last Updated

July 15, 2020

Sponsor

LMU Klinikum

1. Study Identification

Unique Protocol Identification Number

NCT02548611

Brief Title

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

Acronym

SASSICAIA

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2020

Overall Recruitment Status

Terminated

Why Stopped

Due to low recruitment

Study Start Date

September 2015 (Actual)

Primary Completion Date

August 2018 (Actual)

Study Completion Date

November 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

LMU Klinikum

4. Oversight

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Angina Pectoris

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

795 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Prasugrel

Arm Type

Experimental

Arm Description

single-dose loading with 60 mg of prasugrel pre PCI

Arm Title

Clopidogrel

Arm Type

Active Comparator

Arm Description

loading with 600 mg of clopidogrel pre PCI

Intervention Type

Drug

Intervention Name(s)

Prasugrel

Other Intervention Name(s)

Efient

Intervention Description

see arm description

Intervention Type

Drug

Intervention Name(s)

Clopidogrel

Other Intervention Name(s)

Iscover, Plavix

Intervention Description

see arm description

Primary Outcome Measure Information:

Title

Combined ischemic events

Description

Combined outcome of all-cause death, any myocardial infarction (MI), stent thrombosis, urgent revascularization and stroke

Time Frame

30 days

Secondary Outcome Measure Information:

Title

Bleeding

Description

Academic Research Consortium ≥2 bleeding and TIMI classification

Time Frame

30 days

Title

Peri-PCI MI Type 4a

Description

according to Third Universal Definition of MI

Time Frame

30 days

Title

All-cause death

Description

mortality

Time Frame

30 days

Title

Any myocardial infarction

Description

according to SASSICAIA protocol definition

Time Frame

30 days

Title

Stent thrombosis

Description

according to Academic Research Consortium criteria

Time Frame

30 days

Title

Urgent vessel revascularization

Description

revascularization related to symptoms

Time Frame

30 days

Title

cerebro-vascular events

Description

stroke and TIA

Time Frame

30 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Julinda Mehilli, MD

Organizational Affiliation

University Hospital Munich

Official's Role

Principal Investigator

Facility Information:

Facility Name

Universitäts-Herzzentrum Freiburg, Bad Krozingen

City

Freiburg

State/Province

Bad Krozingen

ZIP/Postal Code

79189

Country

Germany

Facility Name

Munich University Hospital

City

Munich

State/Province

Bavaria

ZIP/Postal Code

81377

Country

Germany

Facility Name

Deutsches Herzzentrum Muenchen

City

Munich

ZIP/Postal Code

80636

Country

Germany

Facility Name

Klinikum Bogenhausen

City

Munich

Country

Germany

Facility Name

Heart Center Balatonfüred and Heart and Vascular Center

City

Balatonfüred

Country

Hungary

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

32527192

Citation

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.

Results Reference

derived

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

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