An interventional study of Extended anticoagulation in Embolism and Thrombosis and Anticoagulation, sponsored by Chinese Academy of Medical Sciences, Fuwai Hospital. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-01-18.
Sponsored by Chinese Academy of Medical Sciences, Fuwai Hospital · Not applicable, Interventional, and Treatment
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A single-center, open-label, exploratory randomized controlled study is proposed with the following objectives: whether prolonging the duration of anticoagulation to 12 months, compared with 6 months of routine anticoagulation, helps to reduce major adverse cardiovascular and cerebrovascular events in patients with left ventricular thrombosis and to reduce recurrence of thrombosis, as well as to assess their bleeding risk.
Patients with a definite diagnosis of left ventricular thrombus and age ≥18 years were included in cardiac ultrasound (including general ultrasound and sonography) and other examinations during hospitalization and outpatient visits. Exclusion criteria were detailed in the study protocol.
GROUPING: According to the duration of anticoagulation, they were divided into extended anticoagulation group (12 months) and conventional anticoagulation group (6 months).
INTERVENTION: This study is planned to extend the administration of rivaroxaban (Pulsatilla) 20 mg to 12 months in the experimental group. The conventional anticoagulation group will take the drug for 6 months Study Endpoints: The primary efficacy endpoint is a major cardiovascular-vascular adverse event at 1 year; the primary safety endpoint is bleeding of grade 3 or higher as defined by the BARC classification at 1 year.
Patient Follow-up Program: Subjects will require a total of 12 on-site follow-up visits (one per month) for safety evaluation, efficacy evaluation, medication adherence evaluation, and imaging follow-up at months 3, 6, and 12.
53 studies on the registry are indexed under Embolism and Thrombosis; 11 are open to participants now.
This study's planned enrollment of 220 is below the median of 252 across 28 interventional studies indexed under Embolism and Thrombosis.
Browse Embolism and Thrombosis studies →Chinese Academy of Medical Sciences, Fuwai Hospital is the lead sponsor of 147 studies on the registry; 51 are open to participants now.
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①Patients who have been clearly diagnosed with left ventricular thrombus by inpatient or outpatient cardiac ultrasound (including general ultrasound and acoustic imaging).
②Age >= 18 years old
Exclusion Criteria:
Patients do not agree to participate in the study or have poor compliance in the past
to anticoagulation or allergy to anticoagulants ③Have received oral anticoagulation after diagnosis of left ventricular thrombus.
Have undergone or are planning to undergo surgical procedures including left ventricular appendage thrombectomy, heart transplantation, ventricular wall tumor collapse, or valve replacement.
Presence of other long-term indications for anticoagulation, such as mechanical valve implantation, atrial fibrillation, etc.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Procedure: Extended anticoagulation
This study plan will extend the duration of rivaroxaban 20mg in the experimental group to 12 months. The regular anticoagulation group will take the drug for 6 months
Primary efficacy endpoint
for major cardiovascular and cerebrovascular adverse events at 1 year, including: all-cause mortality, nonfatal heart attack, ischemic stroke, and acute peripheral artery embolism. fatal heart attack, ischemic stroke, and acute peripheral artery embolism
Time frame: Patient completes one year of follow-up
secondary endpoint
Dissolution of left ventricular thrombus confirmed by cardiac ultrasound and no recurrence detected and/or recurrence of left ventricular thrombus detected by cardiac ultrasound after dissolution of left ventricular thrombus
Time frame: Patient during one year of follow-up
Primary safety endpoint
Bleeding of grade 3 or higher as defined by the BARC classification at 1 year
Time frame: Patient during one year of follow-up
No study locations are listed for this record.
Plan to share: No
Start is estimated for Jan 2024; primary completion for Dec 2026, 35 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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Chinese Academy of Medical Sciences, Fuwai Hospital →