Investigation to assess the effects of zalunfiban in patients with an acute heart attack

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Celecor Therapeutics Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

Trial duration

22 Apr 2021 → 18 May 2026

Decision date (initial)

2023-12-20

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

External identifiers

EU CT number

2023-508485-15-00

EudraCT number

2020-003320-16

ClinicalTrials.gov

NCT04825743

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

Efficacy:
To assess the clinical outcome at 30-day follow-up after administration of a single subcutaneous injection of zalunfiban versus placebo in presumed STEMI subjects in the pre-hospital setting
Safety:
To assess bleeding events (according to Global Use of Strategies to Open Occluded Coronary Arteries [GUSTO] severe or life-threatening criterion for safety assessment and, for information only, according to the BARC Type 3C and 5 criteria) after a single subcutaneous injection of zalunfiban versus placebo at 30-day follow-up

Secondary objectives 8

1. Efficacy: To assess after a single subcutaneous injection of zalunfiban versus placebo: Restoration of the culprit coronary artery blood flow (corrected TIMI Frame Count) of the Infarct-Related Artery (Culprit) before intended PCI (or post-coronary angiography in case no PCI is performed)
2. Efficacy: To assess after a single subcutaneous injection of zalunfiban versus placebo: Resolution of ST-segment deviation post-PCI/angiography
3. Efficacy: To assess after a single subcutaneous injection of zalunfiban versus placebo: Blinded bail-out use of IV αIIbβ3 receptor antagonists or IV P2Y12 antagonist at 24 hours post-PCI/angiography
4. Safety: To assess after a single subcutaneous injection of zalunfiban versus placebo: Safety throughout the study by AE reporting
5. Safety: To assess after a single subcutaneous injection of zalunfiban versus placebo: Platelet count before PCI/angiography, at the end of the PCI/angiography, 6 and 24 hours post-PCI/angiography and at hospital discharge/72-hours post-PCI/angiography (whichever occurs first)
6. Safety: To assess after a single subcutaneous injection of zalunfiban versus placebo: Bleeding events (according to International Society on Thrombosis and Haemostasis [ISTH] Major and, for information only, TIMI Major) at 30-day follow-up
7. Safety: To assess after a single subcutaneous injection of zalunfiban versus placebo: Bleeding events (according to GUSTO mild and moderate criteria, BARC Types 2, 3, and 5 criteria, ISTH minor and or major bleeding, TIMI minor and major criteria) at 30-day follow-up
8. Safety: To assess after a single subcutaneous injection of zalunfiban versus placebo: The injection site reactions of a single subcutaneous injection of zalunfiban versus placebo at baseline, 1-hour post-PCI/angiography, hospital discharge/72-hours post-PCI/angiography, and at 30-day follow-up

Conditions and MedDRA coding

Subjects with documented STEMI, presenting with persistent ischemic chest pain (>10 minutes) and new ≥2 mm ST-segment elevation in 2 adjacent ECG leads, in whom the total duration of symptoms to diagnostic ECG is anticipated to be within 4 hours.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Planned transport to participating clinical site.
2. Males aged ≥18 years or post-menopausal or surgically sterile females ≥50 years or ≥55 years (for Czech Republic study sites only).
3. Weight (by history) between 52 and 130 kg (115 and 287 lb).
4. Subjects with documented presumed STEMI, presenting with persistent ischemic chest pain (>10 minutes) and new ≥2 mm ST-segment elevation in 2 adjacent ECG leads, in whom the total duration of symptoms to diagnostic ECG is 4 hours maximum. For selected sites, the diagnostic ECG is obtained at the enrolling site. If time of symptom onset is uncertain, the cardiologist may be contacted to confirm inclusion criteria.
5. Enrollment by EFIC process, verbal witnessed/short written informed consent, or written informed consent signed by subject or legally authorized representative/independent witness will be obtained in the acute phase by (para)medics [according to local applicable legal regulations. This may include both ambulance and clinical site enrollment or clinical site enrollment only, with the sponsor’s approval, if more than 30 minutes of delay is anticipated for door-to-balloon time]. Subject is willing and able to give informed consent. Written informed consent will be obtained as soon as the subject’s clinical condition allows it.

Exclusion criteria 11

1. Cardiopulmonary resuscitation (CPR) for current out-of-hospital cardiac arrest (OHCA).
2. Cardiogenic shock, presenting with systolic blood pressure <90 mmHg (confirmed on repeat assessment) and heart rate >100 beats per minute.
3. Current known active COVID-19 infection (criteria according to local guidelines).
4. Currently treated with renal dialysis.
5. Current treatment with oral anticoagulation (vitamin K antagonists* [VKAs] or direct oral anticoagulants** [DOACs]) and thrombolytic agents***. For example: *acenocoumarol or phenprocoumon, fluindione, and Coumadin (warfarin) **dabigatran, apixaban, edoxaban, rivaroxaban, and betrixaban ***tenecteplase, alteplase, reteplase, streptokinase, and urokinase
6. Major surgery, or trauma or bleeding leading to hospitalization, within the past month.
7. Known history of ischemic or hemorrhagic stroke
8. Known severe anemia (regular blood transfusion needed)
9. Previously enrolled in this study
10. Participation in another clinical study with an investigational product or device within the past month
11. Life expectancy less than one year

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Efficacy: Clinical outcome as assessed on a 7-point scale; ranked from worst to best: 7. Death (all cause) within 30 days of randomization, 6. Stroke within 30 days of randomization, 5. Recurrent MI (yypes 1 to 4 MI) within 30 days of randomization, 4. Acute stent thrombosis within 24 hours post-PCI/angiography, 3. New onset HF or re-hospitalization for HF within 30 days of randomization, 2. MI with hs-cTnT levels ≥30 × ULN within 24 hours +/- 12 hours post study drug admin, 1. None of the above
2. Saferty: Subject incidence of bleeding events (according to GUSTO severe or life-threatening criterion for safety assessment and, for information only, according to the BARC Types 3C and 5 criteria) at 30-day follow-up

Secondary endpoints 8

1. Efficacy: To assess after a single subcutaneous injection of zalunfiban versus placebo: As assessed by an independent Core Laboratory: Corrected TIMI Frame Count of the Infarct-Related Artery (Culprit) before PCI/angiography
2. Efficacy: To assess after a single subcutaneous injection of zalunfiban versus placebo: As assessed by an independent Core Laboratory: ST-segment deviation resolution 1-hour post-PCI/angiography
3. Efficacy: To assess after a single subcutaneous injection of zalunfiban versus placebo: Blinded bail-out use of IV αIIbβ3 receptor antagonists or IV P2Y12 antagonists at 24 hours post-PCI/angiography
4. Safety: To assess after a single subcutaneous injection of zalunfiban versus placebo: Recording of AEs and SAEs. AEs up to 30-day follow-up; SAEs up to resolution/stabilization, the SAEs mortality, hospitalization for HF and atrial fibrillation up to 12-month follow-up
5. Safety: To assess after a single subcutaneous injection of zalunfiban versus placebo: Platelet count before PCI/angiography, at the end of the PCI/angiography, 6 and 24 hours post-PCI/angiography and at hospital discharge/72-hours post-PCI/angiography (whichever occurs first)
6. Safety: To assess after a single subcutaneous injection of zalunfiban versus placebo: Subject incidence of bleeding events (according to ISTH Major and, for information only, TIMI Major) at 30-day follow-up
7. Safety: To assess after a single subcutaneous injection of zalunfiban versus placebo: Subject incidence of bleeding events according to GUSTO mild and moderate criteria, BARC Types 2, 3, and 5 criteria, ISTH minor and or major bleeding, TIMI minor and major criteria at 30-day follow-up
8. Safety: To assess after a single subcutaneous injection of zalunfiban versus placebo: Subject incidence of injection site reactions at baseline, 1-hour post-PCI/angiography, hospital discharge/72-hours post-PCI/angiography, and at 30-day follow-up

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Celecor Therapeutics Inc.

Sponsor organisation

Celecor Therapeutics Inc.

Address

1155 Camino Del Mar, Suit 481 Suit 481

City

Del Mar

Postcode

92014-2605

Country

United States

Scientific contact point

Organisation

Celecor Therapeutics Inc.

Contact name

Robert S. Hillman

Public contact point

Organisation

Celecor Therapeutics Inc.

Contact name

Robert S. Hillman

Third parties 15

Locations

5 EU/EEA countries · 48 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 34 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

10 submissions — initial application plus substantial / non-substantial modifications