A study designed to evaluate a modified Anti-Platelet Therapy (drugs that preventblood platelets from clotting) after implantation of a Firehawk drug-eluting stent (metallic tube, which is covered with a drug and inserted into stenosed blood vessels of the heart in order to keep them open) in patients who have experienced a heart attack and were treated with complete revascularisation (the lesion related to the heart attack and all other significant lesions were treated)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

SORIN CRM SAS (Microport CRM)

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

Trial duration

29 Jun 2021 → 24 Mar 2025

Decision date (initial)

2025-04-14

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

SORIN CRM SAS (Microport CRM)

External identifiers

EU CT number

2024-519854-35-00

EudraCT number

2020-005933-34

ClinicalTrials.gov

NCT04753749

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others, Therapy

The primary objective is to evaluate a modified Anti-Platelet Therapy, associated with low-dose rapamycin DES Firehawk in Acute Myocardial Infarction Patients treated with complete revascularization strategy, in reaching non-inferior NACCE (among clinically stable, low to moderate complexity acute MI patients).

Secondary objectives 1

1. The secondary objective is to evaluate a modified Anti-Platelet Therapy, associated with low-dose rapamycin DES Firehawk in Acute Myocardial Infarction patients treated with complete revascularization strategy, in reducing bleeding events (among clinically stable, low to moderate complexity acute MI patients).

Conditions and MedDRA coding

Acute Myocardial Infarction

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Troponin-positive Non-ST-Elevation MI, requiring early invasive treatment (PCI), or ST-Elevation MI requiring primary PCI, and PCI occurred within the last 7 days
2. Subject is eligible for per-protocol antiplatelet treatments
3. Written informed consent
4. Angiographic criteria: successful revascularization in native coronary arteries only, in vessels with visual reference diameter ≥2.25 mm and ≤ 4.00 mm, implanted with the study device, with a maximum of 3 lesions treated and maximum total stent length ≤ 80 mm
5. Complete revascularization performed when more than 1 significant lesion, during the index procedure or in staged procedure(s) occurring within 7 days from the index procedure.

Exclusion criteria 12

1. Subjects with prior STEMI or prior PCI within 12 months before index admission
2. Prior Coronary Artery Bypass Graft (CABG) Surgery, Prior stent thrombosis, Ischemic stroke or ICH within 12 months
3. Cardiogenic shock, Secondary PCI, Fibrinolysis
4. Planned PCI, CABG, or surgery within 12 months
5. Need for Oral Anti-Coagulation therapy
6. eGFR <30 mL/min/1.73 m2 or dialysis
7. Active bleeding at time of inclusion or high risk for major bleeding (History of bleeding diathesis or coagulopathy or subject refuse blood transfusions, Stage B or C liver cirrhosis or active cancer within 12 months prior to index procedure, Baseline haemoglobin <13 g/dL (12g/dL for women) or anaemia requiring transfusion in the 4 weeks prior to index procedure, Moderate or severe thrombocytopenia)
8. Expected non-adherence to study protocol
9. Known hypersensitivity or contraindication to any medication used in the study or any of the study stent's components/compounds
10. Participation in another interventional clinical trial
11. Angiographic criteria: In-stent restenosis or thrombosis Chronic total occlusion, or Severe calcification, or True bifurcation disease and side branch diameter ≥ 2mm, or bifurcation treated with 2 stents, or Left main coronary artery lesion, or Residual untreated dissection ≥ C, or Implantation of a non-study stent
12. Subject is deemed to receive preferentially CABG within 1 year

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Net Adverse Clinical and Cerebral Events (NACCE) defined as a composite of all cause death, non-fatal myocardial infarction, definite/probable stent thrombosis, stroke, or Bleeding Academic Research Consortium (BARC) type 3 or 5 bleeding at 11 months post randomization (12 months post index procedure).

Secondary endpoints 1

1. The main secondary endpoint is BARC type 2, 3 or 5 bleeding events at 11 months post-randomization.

Investigational products

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

Test 3

Comparator 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

SORIN CRM SAS (Microport CRM)

Sponsor organisation

SORIN CRM SAS (Microport CRM)

Address

4 Avenue Reaumur

City

Clamart

Postcode

92140

Country

France

Scientific contact point

Organisation

SORIN CRM SAS (Microport CRM)

Contact name

Clinical Affairs

Public contact point

Organisation

SORIN CRM SAS (Microport CRM)

Contact name

Clinical Affairs

Third parties 1

Locations

3 EU/EEA countries · 12 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

Summary of results Art. 37(4) CTR

Layperson summary Annex V

Documents 22 files

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

Application history

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