A trial to investigate whether a new medicine, KAND567, is well tolerated and if it can improve healing in patients who have had a heart attack

Phase 2

Completed

• Conditions: ST-elevation myocardial infarction (STEMI); Circulatory System; Acute myocardial infarction

• Registration Number: ISRCTN18402242
• Lead Sponsor: ewcastle upon Tyne Hospitals NHS Foundation Trust

Brief Summary

Funder report results in https://kancera.com/en/mfn_news/kancera-reports-positive-top-line-results-from-the-fractal-study/ (added 16/07/2024)

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-25
• Study Completion: 2023-07-19
• Last Update Posted: 29 July 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 61

Inclusion Criteria

1. Reperfusion of anterior MI expected within 5 hours of onset of acute chest pain
2. Diagnosis of acute myocardial infarction with ST elevation at the J-point in two contiguous leads by ECG (V1-V4 at least two contiguous leads STE 2.0 mm in men and 1.5 mm in women)
3. Agreement to undergo routine procedure of PPCI
4. Aged =18-75 years
5. Willingness and ability to comply with trial procedures, visit schedules, trial restrictions and requirements
6. Confirmation of anterior STEMI (TIMI 0-2 flow) by angiography and occlusion of proximal or mid LAD (segments 5 or 6)
7. Verbal consent to take part in the trial is given

Exclusion Criteria

1. Anyone with known cognitive impairment or unable to provide verbal consent
2. Serious co-existing medical condition, including known hepatic failure and known renal failure with known eGFR <30 ml/min/m² or severe mental disorder, known at the time of randomisation
3. Cardiogenic shock, non-compensated acute heart failure and/or pulmonary edema
4. Previous known major vascular intervention within the last 4 weeks
5. History of previous myocardial infarction (MI) in the LAD
6. Documented left ventricular systolic dysfunction (EF <40%)
7. Previous coronary artery bypass grafting (CABG)
8. Patients unable to tolerate or undergo MRI scanning including patients with claustrophobia, cardiac pacemaker/defibrillator, ferromagnetic metal implants unless approved for use in MRI scanners or excessive body weight
9. Known planned hospitalisations (e.g. elective surgery), or other scheduled treatment for pre-existing conditions during the course of the trial that could interfere with clinical assessment
10. Known allergy to contrast agent or other contraindications for angiography
11. Any known previous diagnosis of invasive cancer within the last 5 years except for treated basal cell carcinoma of the skin
12. Current use of steroids or immunosuppressants
13. Current use of benzodiazepines
14. Current use of ticagrelor (unable to switch to Prasugrel on trial entry)
15. Known pre-existing severe liver disease, including chronic hepatitis or alcohol-dependent liver cirrhosis
16. Other medical or social reasons for exclusion at the discretion of the investigator
17. Administration of any investigational drug within 3 months of trial medication, as far as known to the patient
18. Current use of drug sensitive to CYP3A4 inhibition which cannot be paused or switched to an alternative from the same class of medication for the period of IMP administration, including:
18.1. Certain P2Y12 inhibitors (clopidogrel)
18.2. Certain statins (lovastatin and simvastatin)
19. Women of child-bearing potential who are sexually active who are not using a contraceptive method with a failure rate of <1% to prevent pregnancy prior to trial entry. Postmenopausal women must be amenorrhoeic for at least 12 months prior to randomisation to be considered of non-childbearing potential
20. Women of child-bearing potential who are not willing to use a contraceptive method with a failure rate of <1% to prevent pregnancy throughout the trial
21. Male patients with female partners of childbearing potential not willing to use effective contraception
22. Male patients must agree to refrain from donating sperm whilst participating in the trial

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The safety and tolerability of KAND567 will be assessed on the following:<br>1. Occurrence of adverse events (AEs) during the 90 days trial participation<br>2. Changes in vital signs between baseline and 90 days<br>3. Any change in safety bloods including blood chemistry, haematology and urinalysis will be measured over the period that the participant is in hospital.