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Trial - NCT04510038


Column Value
Trial registration number NCT04510038
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04510038

First author
Last imported at : March 18, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Raul E Herrera, MD

Contact
Last imported at : March 18, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

raulh@baptisthealth.net

Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2020-08-12

Recruitment status
Last imported at : March 18, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Suspended

Study design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Open label

Center
Last imported at : Feb. 23, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

single-center

Study aim
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

inclusion criteria: men and women ≥ 18 years of age cardiac injury (any of the following) elevated troponin level elevated bnp level new ischemic or arrhythmogenic ecg/telemetry changes new decrease in lvef or new pericardial effusion on echocardiogram able to provide informed consent

Exclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

pregnancy, breastfeeding mothers, and women of childbearing age who are unable to use adequate contraception, which includes: intrauterine devices (iud), contraceptive implants, or tubal sterilization hormone method with a barrier method two barrier methods if a partner's vasectomy is the chosen method of contraception, a hormone or barrier method must also be used in conjunction history of severe hematologic or neuromuscular disorder co-administration of cypa3a4 and p-glycoprotein transport inhibitor severe renal impairment with concomitant hepatic impairment concurrent use of colchicine and strong or p-glycoprotein inhibitor with renal or hepatic impairment

Number of arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Miami Cardiac and Vascular Institute

Inclusion age min
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

100

Countries
Last imported at : Feb. 23, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

United States

Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

No restriction on type of patients

Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

0: No restriction on type of patients

Total sample size
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

75

primary outcome
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Mechanical Circulatory Support;Mechanical Ventilation;All Cause Mortality

Notes
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Feb. 25, 2021, 7:58 p.m.
Source : ClinicalTrials.gov

Phase 2/Phase 3

Arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 310, "treatment_name": "Colchicine", "treatment_type": "Metabolic agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]