Strategy To Optimize PeriproCeduraL AnticOagulation in Structural Transseptal Interventions (STOP CLOT Trial)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

Decision date (initial)

2024-12-09

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Medical Research Agency

External identifiers

EU CT number

2024-516376-15-00

EudraCT number

2021-000442-18

ClinicalTrials.gov

NCT05305612

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety, Therapy

Determining the optimal timing for initiating anticoagulation in patients undergoing interventional procedures requiring transseptal puncture, such as Transcatheter Edge-to-Edge Repair (TEER) and Left Atrial Appendage Closure (LAAC).

Conditions and MedDRA coding

periprocedural anticoagulant treatment in patients treated with TEER or transcatheter left atrial appendage closure surgery

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. 1. Age above 18 years. 2. Planned mitral TEER * or LAAC † procedure. 3. Participant expresses willingness to adhere to the study protocol, especially as specified by the protocol for follow-up visits.. 4. The patient is willing to sign informed consent

Exclusion criteria 1

1. 1. Women who are pregnant or breastfeeding and those women of childbearing potential who do not agree to use at least two contraceptive measures (oral contraception, mechanical contraception, approved contraceptive implants, intrauterine device, tubal ligation). The criterion does not apply to women who have been postmenopausal for at least 2 years prior to study enrollment (defined as at least one year without menstrual periods) or underwent surgical sterilization procedure. All eligible women who are younger than 55 years must have negative pregnancy test within 24 hours prior to randomization. 2. Congenital or acquired bleeding disorders (i.e., diagnosed thrombophilia, bleeding diathesis, thrombocytopenia with platelet count <50 thousand/ml, INR elevation >1.5 due to the liver disease). 3. INR >1.5 within 24 hours prior to the procedure in patients chronically treated with vitamin K antagonists (applies to the last INR value prior to randomization). 4. Last dose of new oral anticoagulant <48 hours prior to the procedure (assessed at randomization). 5. Last dose of low molecular weight heparin <12 hours prior to the procedure (assessed at randomization). 6. Contraindications to MR imaging (i.e., claustrophobia, ferromagnetic intraocular foreign bodies, ferromagnetic metallic prostheses). 7. Implanted cardiac devices for electrotherapy if: - device has epicardial leads. - left disconnected leads or non-functional or damaged devices device implanted within abdominal wall. - the patient is pacemaker dependent (lack of escape rhythm >30/min). - the device was implanted or exchanged within 6 weeks prior to the MR. examination - device malfunction identified during the control performed prior to the MR examination, that in the opinion of electrophysiologist team may impact the safety of MR imaging. - low voltage of the device battery: the battery on the examination day should have at least 20% of the voltage value between the nominal value and elective replacement indicator (ERI) value, or the expected battery life calculated by the device should equal or exceed one year.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The primary efficacy endpoint is a composite of the following: 1 major adverse cardiac and cerebrovascular events (MACCE; death, stroke, transient ischemic attack [TIA], myocardial infarction, or peripheral embolization) within 30 days after procedure; 2 intraprocedural new thrombus formation in the right or left atrium as assessed with periprocedural TEE; or 3 occurrence of new ischemic lesions with diameter ≥4 mm on brain MRI performed 2 to 5 days after the procedure.

Secondary endpoints 1

1. The secondary/efficacy safety endpoint: moderate or severe bleeding complications (BARC 2-5) including cardiac tamponade requiring intervention during the index hospitalization; 1 intraprocedural new thrombus formation in the right or left atrium as assessed by periprocedural TEE; 2 occurrence of new ischemic brain lesions on MRI performed within 2 to 5 days after the index procedure; or 3 MACCE (death, stroke, TIA, peripheral embolization, myocardial infarction) within 30 days from the index

Investigational products

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

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy

Sponsor organisation

Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy

Address

Alpejska 42

City

Warsaw

Postcode

04-628

Country

Poland

Scientific contact point

Organisation

Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy

Contact name

Clinical Research Support Centre Information Desk

Public contact point

Organisation

Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy

Contact name

Clinical Research Support Centre Information Desk

Locations

1 EU/EEA country · 6 investigational sites

By country

Investigational sites

Results and documents

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

Documents 7 files

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

Application history

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