CardioLogical Interventions and Acute strOke Treatment sTudy (CLOT)

January 4, 2026 updated by: Simona Sacco, University of L'Aquila
The study aims to investigate characteristics and prognosis of ischemic stroke cases following cardiological interventions, focusing on the effectiveness and safety of acute ischemic stroke treatments.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

CLOT is a multicenter, observational, ambispective real-world study involving acute ischemic stroke cases occuring after cardiological procedures.

Patients will be recruited at different emergency services and stroke units in Europe. The study will encompass a retrospective (CLOT-R) and prospective (CLOT-P) data collection.

CLOT-R will include cases the occured in the 5 years befor the initation of the study; CLOT-P has a duration of 2 years of enrollement from the study approval at each site and follow-up of 180 days (total duration of 2 years and 180 days). The inclusion criteria are: acute ischemic stroke in adult patient (18 years of age or older) as diagnosed according to the World Health Organization (WHO) criteria; stroke with evidence of CT/MRI DWI/FLAIR acute lesion in the first neuroimaging or in the follow-up at 24-48 h; interventional cardiological procedures performed within 28 days since the stroke onset (Percutaneuous Coronary Intervention - PCI, Transcatheter Aortic Valve Replacement - TAVR, Baloon Aortic Valvuloplasy - BAV, Percutaneous Mitral Valve Repair or Replacement, Patent Formaen Ovale - PFO - or Atrial Septal Defects - ASD - Closure, Left Atrial Appendage Closure, Transcatheter Pulmonary Valve Replacement, Percutaneous Closure of Paravalvular Leaks); written informed consent provided by the patient himself or by proxy (for unconscious patients, cognitively impaired, or aphasic).

Exclusion criteria are: Stroke-like symptoms due primarily to another non-ischemic/hemorrhagic acute neurological condition or stroke mimics (e.g. severe hypo- or hyperglycemia, migraine with aura, functional disorders, etc); Spontaneous and post traumatic hemorrhagic stroke or spontaneous/post-traumatic subarachnoid hemorrhage or subdural hematoma; Impossibility to achieve written informed consent.

The primary outcome of CLOT-R is a descriptive analysis of baseline demographic, clinical, neuroimaging, cardiological procedural and acute stroke treatment characteristics. The secondary outcomes are: effectiveness and safety of intravenous thrombolysis (IVT) with or without mechanical thrombectomy (MT), or MT alone; 90-day post-stroke risk of all-cause and vascular mortality, new ischemic stroke or transient ischemic attack (TIA), myocardial infarction, intracranial hemorrhage or other major bleeding events, disability as measured by the modified Rankin Scale (mRS) score.

The primary outcome of CLOT-P is effectiveness and safety of IVT with or without MT, or MT alone. The secondary outcomes are 90-day and 180-day post-stroke risk of all-cause and vascular mortality, new ischemic stroke or TIA, myocardial infarction, intracranial hemorrhage or other major bleeding events, disability as measured by the mRS score.

The statistic analyses will include Descriptive statistics (baseline characteristics), Poisson regression analysis (incidence of primary and secondary outcomes at each timepoint), Cox regression analysis (time-to-outcomes comparison between groups, identification of outcomes predictors), generalized linear regression (ordinal mRS distribution comparison between maintainers and switchers), risk ratio and risk difference calculation for primary and secondary outcomes comparison (unadjusted and adjusted for confounders), pseudo-randomization (propensity score matching or inverse probability weighting).

The study aims to include in CLOT-P a minimum sample of 400 patients (100 patients for each acute stroke treatment group and 100 untreated) to have reliable estimates of the primary study outcome.

Study Type

Observational

Enrollment (Estimated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
    • L'Aquila
      • L’Aquila, L'Aquila, Italy, 67100
        • Department of Biotechnological and Applied Clinical Sciences
        • Sub-Investigator:
          • Federico De Santis, MD
        • Contact:
        • Contact:
        • Principal Investigator:
          • Lucio D'Anna, MD, PhD
        • Sub-Investigator:
          • Francesca Gabriele, MD
        • Sub-Investigator:
          • Paola Colantuono, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Acute ischemic stroke in adult patient (>18 years old) after cardiological intervention, male and female.

Description

Inclusion Criteria:

  • acute ischemic stroke in adult patient (18 years of age or older) as diagnosed according to the World Health Organization (WHO) criteria;
  • stroke with evidence of CT/MRI DWI/FLAIR acute lesion in the first neuroimaging or in the follow-up at 24-48 h;
  • interventional cardiological procedures performed within 28 days since the stroke onset (Percutaneuous Coronary Intervention - PCI, Transcatheter Aortic Valve Replacement - TAVR, Baloon Aortic Valvuloplasy - BAV, Percutaneous Mitral Valve Repair or Replacement, Patent Formaen Ovale - PFO - or Atrial Septal Defects - ASD - Closure, Left Atrial Appendage Closure, Transcatheter Pulmonary Valve Replacement, Percutaneous Closure of Paravalvular Leaks);
  • written informed consent provided by the patient himself or by proxy (for unconscious patients, cognitively impaired, or aphasic).

Exclusion Criteria:

  • Stroke-like symptoms due primarily to another non-ischemic/hemorrhagic acute neurological condition or stroke mimics (e.g. severe hypo- or hyperglycemia, migraine with aura, functional disorders, etc);
  • Spontaneous and post traumatic hemorrhagic stroke or spontaneous/post-traumatic subarachnoid hemorrhage or subdural hematoma;
  • AciuImpossibility to achieve written informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patients with ischemic stroke occuring within 28 days after cardiological interventional procedures
Cardiological interventions includes: Percutaneuous Coronary Intervention - PCI, Transcatheter Aortic Valve Replacement - TAVR, Baloon Aortic Valvuloplasy - BAV, Percutaneous Mitral Valve Repair or Replacement, Patent Formaen Ovale - PFO - or Atrial Septal Defects - ASD - Closure, Left Atrial Appendage Closure, Transcatheter Pulmonary Valve Replacement, Percutaneous Closure of Paravalvular Leaks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CLOT-R primary outcome - Stroke severity
Time Frame: from enrollment to 180 days follow-up
Stroke severity assessed via the National Institutes of Health Stroke Scale (NIHSS). Scores on the NIHSS range from 0 to 42, with higher scores indicating more severe neurological deficits.
from enrollment to 180 days follow-up
CLOT-R primary outcome - Radiology
Time Frame: from enrollment to 180-day follow-up
Number of participants with large vessel occlusion demonstrated on neuroimaging.
from enrollment to 180-day follow-up
CLOT-R primary outcome - Cardiological procedure
Time Frame: from enrollment to 180-day follow-up
Number of participants who underwent cardiological procedures during which ischemic stroke occurred.
from enrollment to 180-day follow-up
CLOT-P primary outcome - Efficacy
Time Frame: 90-day follow-up
Number of participants presenting with Modified Rankin Scale (mRS) score ≤2 after revascularization. Scores on the mRS range from 0 to 6, with 0 indicating no symptoms and 6 indicating death. A score of 2 or less indicates functional indipendence.
90-day follow-up
CLOT-P primary outcome - safety
Time Frame: 90-day follow-up
Number of participants with symptomatic intracranial hemorrhage after revascularization.
90-day follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CLOT-R secondary outcome - Efficacy
Time Frame: 90-day follow-up
Number of participants presenting with Modified Rankin Scale (mRS) score ≤2 after revascularization. Scores on the mRS range from 0 to 6, with 0 indicating no symptoms and 6 indicating death. A score of 2 or less indicates functional indipendence.
90-day follow-up
CLOT-R secondary outcome - Safety
Time Frame: 90-day follow-up
Number of patients with symptomatic intracranial hemorrhage after revascularization.
90-day follow-up
CLOT-R secondary outcome: Serious Adverse Event (SAE)
Time Frame: 90-day follow-up
Number of patients experiencing Serious Adverse Events (retrospective investigation).
90-day follow-up
CLOT-P secondary outcome: Serious Adverse Event (SAE)
Time Frame: 90-day and 180-day follow-up
Number of patients experiencing Serious Adverse Events (prospective investigation).
90-day and 180-day follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of L'Aquila

Collaborators

Rete delle NeuroCardiologie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2026

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

December 2, 2025

First Submitted That Met QC Criteria

December 17, 2025

First Posted (Estimated)

January 2, 2026

Study Record Updates

Last Update Posted (Actual)

January 7, 2026

Last Update Submitted That Met QC Criteria

January 4, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1.0 - 08/02/2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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