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Prevalence of Cardiac Thrombi in Cardiac Amyloidosis

Study acronym: CATICA
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 years 1 month later across 2 updates Jul 2028 → Sep 7, 2030
See other at-risk trials from Centre Hospitalier Universitaire Dijon

Record History

  1. Notable Primary and study completion pushed from Sep 2028 to Sep 7, 2030 Recruitment opened · Primary and study completion pushed from Jul 2028 to Sep 2028 · Start date moved earlier from Sep 10, 2026 to Sep 7, 2026 Show 3 more changesShow less
    • Recruitment opened
    • Primary and study completion pushed from Jul 2028 to Sep 2028
    • Start date moved earlier from Sep 10, 2026 to Sep 7, 2026
  2. Notable Trial status: Not Yet Recruiting to Recruiting Primary and study completion dates: Jul 2028 to Sep 2028 · Start date changed from estimate of Jul 2026 to Sep 10, 2026 · Eligibility criteria expanded, about 13 words · 1 more Show 4 more changesShow less
    • Primary and study completion dates: Jul 2028 to Sep 2028
    • Start date changed from estimate of Jul 2026 to Sep 10, 2026
    • Eligibility criteria expanded, about 13 words
    • Site details revised
  3. Minor Re-verified, no change to tracked fieldsv2
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Cardiac amyloidosis (CA) is an infiltrative disease characterized by deposits of amyloid proteins of genetic or acquired origin (often in elderly patients), leading to heart failure and arrhythmias. More than 98% of currently diagnosed cases of cardiac amyloidosis result from fibrils composed of monoclonal immunoglobulin light chains (AL) or transthyretin (ATTR), in its hereditary (ATTRv) or acquired (ATTRwt) form. Its prevalence is rising sharply due to an aging population and improved diagnostic techniques. Atrial fibrillation is responsible, in particular, for heart failure, arrhythmias, conduction disorders, and ischemic strokes, and is associated with significant morbidity and mortality. These patients have a much higher-than-normal risk of stroke because they are in a procoagulant state in the left atrium, even in the absence of atrial fibrillation. Intracardiac thrombi (ICTs) are present in 28% of patients with AC requiring cardioversion, compared with 2.5% of patients without AC, 50% of whom are on anticoagulants. It has also been shown that the CHA2DS2-VASc score is not effective in predicting thromboembolic risk, and that direct oral anticoagulants (DOACs) are as effective as vitamin K antagonists (VKAs) in preventing embolisms. The prevalence and factors associated with the development of intracardiac thrombi in patients with cardiac amyloidosis are unknown, as the available retrospective studies focused only on selected high-risk patients. Furthermore, tafamidis is now available to stabilize the course of cardiac amyloidosis and improve prognosis, but its effect on thromboembolic risk remains unknown.
Trial Details
NCT Number NCT07648303
Lead Sponsor Centre Hospitalier Universitaire Dijon
Conditions Cardiac Amyloidosis
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov