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Background
Thrombolysis is an alternative to surgery for mechanical prosthetic valve thrombosis (MPVT). Randomized clinical trials have yet to test safety and efficacy of a proposed ultraslow thrombolytic infusion regimen.
Methods and Results
This single-center, open-label, pilot randomized clinical trial randomized adult patients with acute obstructive MPVT to an ultraslow thrombolytic regimen (25 mg of recombinant tissue-type plasminogen activator [rtPA] infused in 25h) and a fast thrombolytic regimen (50 mg of rtPA infused in 6h). If thrombolysis failed, a repeated dose of 25 mg of rtPA for 6h was administered in both groups up to a cumulative dose of 150 mg or the occurrence of a complication. Primary outcome was a complete MPVT resolution (>75% fall in the obstructive gradient by transthoracic echocardiography, <10° limitation in opening and closing valve motion angles by fluoroscopy, and symptom improvement). Key safety outcome was a BARC type III or V major bleeding. Overall, 120 patients, including 63 (52.5%) women, at a mean age of 36.3±15.3 years, were randomized. Complete thrombolysis success was achieved in 51 patients (85.0%) in the ultraslow-regimen group and 47 patients (78.3%) in the fast-regimen group (OR, 1.58; 95% CI, 0.25 to 1.63; P = 0.34). One case of transient ischemic attack and 3 cases of intracranial hemorrhage (absolute risk difference, −12.5%; 95% CI, −23.1% to −1.0%; P = 0.04). were observed only in the fast-regimen group.
Conclusions
The ultraslow thrombolytic regimen conferred a high thrombosis resolution rate without major complications. Such findings should be replicated in more adequately powered trials (IRCT20181022041406N2).
Background Thrombolysis is an alternative to surgery for mechanical prosthetic valve thrombosis (MPVT). Randomized clinical trials have yet to test safety and efficacy of a proposed ultraslow thrombolytic infusion regimen. Methods and Results This single-center, open-label, pilot randomized clinical trial randomized adult patients with acute obstructive MPVT to an ultraslow thrombolytic regimen (25 mg of recombinant tissue-type plasminogen activator [rtPA] infused in 25h) and a fast thrombolytic regimen (50 mg of rtPA infused in 6h). If thrombolysis failed, a repeated dose of 25 mg of rtPA for 6h was administered in both groups up to a cumulative dose of 150 mg or the occurrence of a complication. Primary outcome was a complete MPVT resolution (>75% fall in the obstructive gradient by transthoracic echocardiography, <10° limitation in opening and closing valve motion angles by fluoroscopy, and symptom improvement). Key safety outcome was a BARC type III or V major bleeding. Overall, 120 patients, including 63 (52.5%) women, at a mean age of 36.3±15.3 years, were randomized. Complete thrombolysis success was achieved in 51 patients (85.0%) in the ultraslow-regimen group and 47 patients (78.3%) in the fast-regimen group (OR, 1.58; 95% CI, 0.25 to 1.63; P = 0.34). One case of transient ischemic attack and 3 cases of intracranial hemorrhage (absolute risk difference, −12.5%; 95% CI, −23.1% to −1.0%; P = 0.04). were observed only in the fast-regimen group. Conclusions The ultraslow thrombolytic regimen conferred a high thrombosis resolution rate without major complications. Such findings should be replicated in more adequately powered trials (IRCT20181022041406N2).
Protocol summary
Study aim
Comparison of fast versus ultraslow infusion of thrombolytic regimen in patients with mechanical prosthetic valve thrombosis
Design
Two parallel groups randomized trial with blinded outcome assessment
Settings and conduct
The trial will be held in a hospital setting (Rajaie Cardiovascular Medical and Research center) on patients with mechanical prosthetic valve thrombosis . Patients will be randomized via central web based method into two interventional groups with two different thrombolytic regimen. Treating physician and patients will not be blinded. Thrombus resolution and degree of valve openingwill be evaluated by echocardiography after thrombolytic therapy. Also thrombolytic complication will be evaluated during hospitalization.
Participants/Inclusion and exclusion criteria
Inclusion criteria: provision of signed and dated informed consent form; patients with prosthetic mechanical valve thrombosis approved by echocardiography; men and women ≥ 18 year-old.
Exclusion criteria: contraindication of thrombolytic therapy; dyspnea of functional class 4; thrombus size larger than 0.8 cm2.
Intervention groups
In this study there are two interventional groups: first group: patients will receive fast thrombolytic regimen. Second group: patients will receive ultra slow thrombolytic regimen.
Comparison of fast versus ultraslow infusion of thrombolytic in patients with mechanical prosthetic valve thrombosis- A randomized controlled trial
Public title
Thrombolytic in mechanical prosthetic valve thrombosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Provision of signed and dated informed consent form
Patients with prosthetic mechanical valve thrombosis approved by echocardiography
Men and women ≥ 18 year-old
Exclusion criteria:
Contraindication of thrombolytic therapy
Dyspnea of functional class 4
Thrombus size larger than 0.8 cm2
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be performed via permuted block randomization method. Allocation will be generated via a web based system and consequently concealment will be central using computer software. Unit of randomization will be individual patients and no stratification will be applied.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Rajaie Cardiovascular Medical and Research Center Ethic committee
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rajaie cardiovascular medical and research center
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Rajaie cardiovascular medical and research center
Full name of responsible person
Parham Sadeghipour
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Vali-Asr Ave, Hashemi Rafsanjani Exp
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 2392 2092
Email
psadeghipour@rhc.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rajaie cardiovascular medical and research center
Full name of responsible person
Parham Sadeghipour
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Vali-Asr Ave, Hashemi Rafsanjani Exp
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 2392 2092
Email
psadeghipour@rhc.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Rajaie cardiovascular medical and research center
Full name of responsible person
Parham Sadeghipour
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Vali-Asr Ave, Hashemi Rafsanjani Exp
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 2392 2092
Email
psadeghipour@rhc.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Trial results
Please tick if results have been published
Yes
Summary result posting date
2021-12-11, 1400/09/20
Table of baseline comparison
Participant flow diagram
Table of variable outcomes' results
Table of adverse events
First publication date
2021-12-04, 1400/09/13
Abstract of published paper
Background
Thrombolysis is an alternative to surgery for mechanical prosthetic valve thrombosis (MPVT). Randomized clinical trials have yet to test safety and efficacy of a proposed ultraslow thrombolytic infusion regimen.
Methods and Results
This single-center, open-label, pilot randomized clinical trial randomized adult patients with acute obstructive MPVT to an ultraslow thrombolytic regimen (25 mg of recombinant tissue-type plasminogen activator [rtPA] infused in 25h) and a fast thrombolytic regimen (50 mg of rtPA infused in 6h). If thrombolysis failed, a repeated dose of 25 mg of rtPA for 6h was administered in both groups up to a cumulative dose of 150 mg or the occurrence of a complication. Primary outcome was a complete MPVT resolution (>75% fall in the obstructive gradient by transthoracic echocardiography, <10° limitation in opening and closing valve motion angles by fluoroscopy, and symptom improvement). Key safety outcome was a BARC type III or V major bleeding. Overall, 120 patients, including 63 (52.5%) women, at a mean age of 36.3±15.3 years, were randomized. Complete thrombolysis success was achieved in 51 patients (85.0%) in the ultraslow-regimen group and 47 patients (78.3%) in the fast-regimen group (OR, 1.58; 95% CI, 0.25 to 1.63; P = 0.34). One case of transient ischemic attack and 3 cases of intracranial hemorrhage (absolute risk difference, −12.5%; 95% CI, −23.1% to −1.0%; P = 0.04). were observed only in the fast-regimen group.
Conclusions
The ultraslow thrombolytic regimen conferred a high thrombosis resolution rate without major complications. Such findings should be replicated in more adequately powered trials (IRCT20181022041406N2).