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

NCT02548611 | Terminated Phase 4 DMC

• 1 other identifier: GE IDE MucT002-14
• Study Type: interventional
• Target: 795
• Locations: 2 countries
• Sites: 5

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.

Conditions

Angina Pectoris

Outcome Measures

Primary Outcomes (1)

• Combined ischemic events

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

  30 days

Secondary Outcomes (7)

• Bleeding

  30 days

• Peri-PCI MI Type 4a

  30 days

• All-cause death

  30 days

• Any myocardial infarction

  30 days

• Stent thrombosis

  30 days

Study Arms (2)

Prasugrel

EXPERIMENTAL

single-dose loading with 60 mg of prasugrel pre PCI

Drug: Prasugrel

Clopidogrel

ACTIVE COMPARATOR

loading with 600 mg of clopidogrel pre PCI

Drug: Clopidogrel

Interventions

Prasugrel DRUG

see arm description

Also known as: Efient

Prasugrel

Clopidogrel DRUG

see arm description

Also known as: Iscover, Plavix

Clopidogrel

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with biomarker negative stable or unstable angina pectoris
• Written informed consent
• In women with childbearing potential a pregnancy test is obligatory

You may not qualify if:

• 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

Sponsors & Collaborators

• LMU Klinikum: lead

Study Sites (5)

Universitäts-Herzzentrum Freiburg, Bad Krozingen

Freiburg im Breisgau, Bad Krozingen, 79189, Germany

Location

Munich University Hospital

Munich, Bavaria, 81377, Germany

Location

Deutsches Herzzentrum Muenchen

Munich, 80636, Germany

Location

Klinikum Bogenhausen

Munich, Germany

Location

Heart Center Balatonfüred and Heart and Vascular Center

Balatonfüred, Hungary

Location

Related Publications (1)

• 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.

  PMID: 32527192 DERIVED

MeSH Terms

Conditions

Angina Pectoris

Interventions

Prasugrel Hydrochloride; Clopidogrel

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Ticlopidine; Thienopyridines; Pyridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Julinda Mehilli, MD

  University Hospital Munich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med.

Study Record Dates

• First Submitted: September 10, 2015
• First Posted: September 14, 2015
• Study Start: September 1, 2015
• Primary Completion: August 1, 2018
• Study Completion: November 1, 2018
• Last Updated: July 17, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (4); HU (1)