NCT02390674

Brief Summary

Routine primary percutaneous coronary intervention (PPCI) for a heart attack involves opening a blocked artery with a balloon then inserting a metal scaffold (stent) to hold the artery open. During this procedure inflammation can occur causing further damage to the heart. The objective of this trial is to determine whether administration of the drug ciclosporin prior to PPCI reduces the amount of damage to the heart relative to treatment with placebo. The damage to the heart is assessed after 12 weeks by an magnetic resonance imaging (MRI) scan. Patients are followed-up after 12 months participation in the study. This is a single centre study looking to recruit 68 patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Mar 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

March 11, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 17, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 11, 2017

Completed
Last Updated

March 29, 2018

Status Verified

March 1, 2018

Enrollment Period

2.1 years

First QC Date

March 11, 2015

Last Update Submit

March 27, 2018

Conditions

Myocardial Reperfusion Injury

Outcome Measures

Primary Outcomes (1)

  • Change in infarct size

    Change in infarct size 12 weeks post-PPCI as measured by cardiac MRI

    12 weeks after primary percutaneous coronary intervention (PPCI)

Secondary Outcomes (3)

  • Change in microvascular obstruction

    Measured once between day 2 and day 7 after PPCI

  • Change in salvage index

    Measured once between day 2 and day 7 after PPCI

  • Change in T lymphocyte count

    5, 15, 30, 60 and 90 minutes

Study Arms (2)

Ciclosporin

ACTIVE COMPARATOR

Single intravenous administration of ciclosporin (2.5mg per kilogram body weight) immediately prior to reperfusion during primary percutaneous coronary intervention. Ciclosporin is dissolved in saline (maximum concentration 2.5mg per millilitre)

Drug: Ciclosporin

Saline

PLACEBO COMPARATOR

Single intravenous administration of placebo (saline) immediately prior to reperfusion during primary percutaneous coronary intervention

Drug: Saline

Interventions

CiclosporinDRUG

Comparison between ciclosporin and placebo

Also known as: Sandimmun
Ciclosporin
SalineDRUG
Saline

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients presenting with acute myocardial infarction (STEMI) and undergoing primary percutaneous coronary intervention (PPCI)
  • Age above 18 years
  • Presenting within 6 hours of the onset chest pain and ST segment elevation. The culprit coronary artery has to be a major coronary artery with a diameter of at least 3mm and has to be proximally occluded (TIMI flow grade 0-1) at the time of admission coronary angiography

You may not qualify if:

  • Patients with any disorder associated with immunological dysfunction (acute or chronic inflammatory or neoplastic co-existing disease, known positive serology for HIV, or hepatitis)
  • Clinically unstable patients (haemodynamically unstable, cardiogenic shock, unconscious patients)
  • Patients with evidence of coronary collaterals to the infarct area
  • Patients with an open (TIMI \> 1) culprit coronary artery at the time of angiography.
  • Previous myocardial infarction
  • Previous thrombolytic therapy
  • Patients with known hypersensitivity to ciclosporin or to egg, peanut or soya-bean proteins.
  • Patients with known renal insufficiency (either known glomerular filtration rate (GFR) \<30 ml/min/1.73m2) or current medical care for severe renal insufficiency.
  • Known liver insufficiency
  • Uncontrolled hypertension (\>180/110 mmHg)
  • Patients treated with any compound containing hypericum perforatum, stiripentol, Aliskiren, Bosentan or Rosuvastatin or with an active treatment that might modify blood concentration of ciclosporin.
  • Female patients currently pregnant or women of childbearing age who are not using contraception (verbal diagnosis). Female patients of childbearing potential who are using contraception but are subsequently found to have a positive urine pregnancy test (pregnancy test performed as soon as reasonably practicable after investigational medicinal product (IMP) administration).
  • Contraindication to cardiac MRI:
  • Pacemaker
  • Implantable defibrillator
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Newcastle Clinical Trials Unit

Newcastle upon Tyne, Tyne and Wear, NE2 4AE, United Kingdom

Location

Related Publications (2)

  • Gatsiou A, Tual-Chalot S, Napoli M, Ortega-Gomez A, Regen T, Badolia R, Cesarini V, Garcia-Gonzalez C, Chevre R, Ciliberti G, Silvestre-Roig C, Martini M, Hoffmann J, Hamouche R, Visker JR, Diakos N, Wietelmann A, Silvestris DA, Georgiopoulos G, Moshfegh A, Schneider A, Chen W, Guenther S, Backs J, Kwak S, Selzman CH, Stamatelopoulos K, Rose-John S, Trautwein C, Spyridopoulos I, Braun T, Waisman A, Gallo A, Drakos SG, Dimmeler S, Sperandio M, Soehnlein O, Stellos K. The RNA editor ADAR2 promotes immune cell trafficking by enhancing endothelial responses to interleukin-6 during sterile inflammation. Immunity. 2023 May 9;56(5):979-997.e11. doi: 10.1016/j.immuni.2023.03.021. Epub 2023 Apr 25.

    PMID: 37100060DERIVED

  • Cormack S, Mohammed A, Panahi P, Das R, Steel AJ, Chadwick T, Bryant A, Egred M, Stellos K, Spyridopoulos I; CAPRI investigators. Effect of ciclosporin on safety, lymphocyte kinetics and left ventricular remodelling in acute myocardial infarction. Br J Clin Pharmacol. 2020 Jul;86(7):1387-1397. doi: 10.1111/bcp.14252. Epub 2020 Mar 11.

    PMID: 32067256DERIVED

MeSH Terms

Conditions

Myocardial Reperfusion Injury

Interventions

CyclosporineSodium Chloride

Condition Hierarchy (Ancestors)

CardiomyopathiesHeart DiseasesCardiovascular DiseasesMyocardial IschemiaVascular DiseasesReperfusion InjuryPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CyclosporinsPeptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsPeptidesAmino Acids, Peptides, and ProteinsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Ioakim Spyridopoulos, PhD, MD

    Newcastle University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2015

First Posted

March 17, 2015

Study Start

March 1, 2015

Primary Completion

April 1, 2017

Study Completion

November 11, 2017

Last Updated

March 29, 2018

Record last verified: 2018-03

Locations

GB(1)