Testing a new treatment for patients with heart disease

Phase 1

• Conditions: Acute Coronary Syndrome (ACS) such as myocardial infarction and unstable angina; MedDRA version: 20.0Level: PTClassification code 10051592Term: Acute coronary syndromeSystem Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2017-005130-27-GB
• Lead Sponsor: Cambridge University Hospitals NHS Foundation Trust and University of Cambridge

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-20
• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

To be included in the trial the participant must meet the following criteria:
- Able to provide written informed consent to participate.
- Age between 18 and 85
- Current admission (on the screening visit) with an ACS with symptoms suggestive of mycardial ischaemia lasting 10 minutes or longer with the patient at rest or with minimal effort and EITHER i) elevated levels of TnI on admission OR ii) dynamic changes in ECG (new ST-T changes, T-wave inversion).
- Where applicable, to be included in the trial women must be: i. Postmenopausal (for the purposes of this trial, postmenopausal is defined as being amenorrhoeic for greater than 2 years with an appropriate clinical profile, e.g. age appropriate, history of vasomotor symptoms) OR ii. Have had a documented hysterectomy and/or bilateral oophorectomy OR sterilisation OR iii. Peri-menopausal with a negative pregnancy test at screening (for the purposes of this trial, perimenopausal is defined as women with an appropriate clinical profile, e.g. age appropriate, history of vasomotor symptoms, irregular periods). These women will be expected to comply with the use of contraception for the duration of the trial and undergo additional pregnancy tests during and after treatment.
- High sensitivity C-reactive protein of >2 mg/L at screening
- Willingness and possibility to start dosing within 8 days from initial date of admission to the primary hospital for ACS
- Able to comply with all trial mandated visits

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

- Current presentation (at screening) with cardiogenic shock (systolic blood pressure <80 mm Hg, that is unresponsive to fluids, or necessitates administration of catecholamines)
- Current presentation with cardiac arrest
- Signs or symptoms of active infection requiring intravenous antibiotic treatment at screening
- History of malignancies requiring active treatment (However, patients with a history of treated localised basal or squamous cell skin cancer are not excluded from participation in this trial)
- History of solid organ transplantation or other bone marrow transplantation
- History of recurrent epileptic seizures in the previous 4 years; repetitive or difficult to control seizures, coma or toxic psychosis lasting >48 hours
- Uncontrolled hypotension (Systolic BP (SBP)<80mmHg or DBP<50mmHg) OR uncontrolled hypertension (SBP>180 or DBP>120 mmHg) at screening
- Average corrected QT interval (QTc) > 450 msecs using Bazett’s formula from average of triplicate ECGs (or > 480 msecs if bundle branch block)
- Renal impairment defined as Creatinine clearance [Cockcroft-Gault] <45ml/min at screening
- Liver dysfunction (defined as ALT > 2xULN) at screening
- Evidence of cholestasis defined as elevated Total Bilirubin Levels, (TBL > 1.5 x ULN) and Alkaline Phosphatase, ALP (ALP > 1.5 x ULN), at screening
- Known hypothyroidism or hyperthyroidism
- Known autoimmune disease requiring active immunosuppressive treatment
- Any regular oral or intravenous immunosuppressive treatment including prednisolone, hydrocortisone or disease modifying drugs. [Inhaled or topical steroids are permissible]
- Patients on cytotoxic drugs and interferon-alpha
- Known Type 1 or Type 2 diabetes mellitus
- Contraindication to IL-2 treatment or hypersensitivity to IL-2 or to any of its excipients
- Participation in a previous research trial in the last 3 years which involved exposure to significant ionising radiation (i.e. cumulative research radiation dose >5 mSv)
- Participation in a clinical trial where the patient has received a drug or new chemical entity within 30 days or 5 half-lives, or twice the duration of the biological effect of the drug (whichever is longer) prior to the first dose of trial medication, Visit 3 (Day 1).
- Any medical history or clinically relevant abnormality that is deemed by the principal investigator/delegate to make the patient ineligible for inclusion because of a safety concern
- Pregnant women or breastfeeding women.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified