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Preventing Cardiac Complication of COVID-19 Disease With Early Acute Coronary Syndrome Therapy: A Randomised Controlled Trial. (C-19-ACS)

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ClinicalTrials.gov Identifier: NCT04333407
Recruitment Status : Recruiting
First Posted : April 3, 2020
Last Update Posted : April 9, 2020
Sponsor:
Information provided by (Responsible Party):
Imperial College London

Tracking Information
First Submitted Date  ICMJE April 1, 2020
First Posted Date  ICMJE April 3, 2020
Last Update Posted Date April 9, 2020
Actual Study Start Date  ICMJE April 3, 2020
Estimated Primary Completion Date March 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 3, 2020)
All-cause mortality at 30 days after admission [ Time Frame: at 30 days after admission ]
All-cause mortality
Original Primary Outcome Measures  ICMJE
 (submitted: April 1, 2020)
Primary Efficacy Outcome [ Time Frame: at 30 days after admission ]
All-cause mortality
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 3, 2020)
  • Absolute change in serum troponin from admission to peak value [ Time Frame: within 7 days and within 30 days of admission ]
    Absolute change in serum troponin from admission (or from suspicion/diagnosis of Covid-19 if already an inpatient) measurement to peak value (measured using high sensitivity troponin assay). (Phase I interim analysis)
  • Discharge Rate [ Time Frame: at 7 days and 30 days after admission ]
    Discharge Rate: Proportion of patients discharged (or documented as medically fit for discharge)
  • Intubation Rate [ Time Frame: at 7 days and at 30 days after admission ]
    Intubation Rate: Proportion of patients who have been intubated for mechanical ventilation
Original Secondary Outcome Measures  ICMJE
 (submitted: April 1, 2020)
  • Secondary Efficacy Outcome 1 [ Time Frame: within 7 days and within 30 days of admission ]
    Absolute change in serum troponin from admission (or from suspicion/diagnosis of Covid-19 if already an inpatient) measurement to peak value (measured using high sensitivity troponin assay). (Phase I interim analysis)
  • Secondary Efficacy Outcome 2 [ Time Frame: at 7 days and 30 days after admission ]
    Discharge Rate: Proportion of patients discharged (or documented as medically fit for discharge)
  • Secondary Efficacy Outcome 3 [ Time Frame: at 7 days and at 30 days after admission ]
    Intubation Rate: Proportion of patients who have been intubated for mechanical ventilation
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Preventing Cardiac Complication of COVID-19 Disease With Early Acute Coronary Syndrome Therapy: A Randomised Controlled Trial.
Official Title  ICMJE Preventing Cardiac Complication of COVID-19 Disease With Early Acute Coronary Syndrome Therapy: A Randomised Controlled Trial.
Brief Summary

The outbreak of a novel coronavirus (SARS-CoV-2) and associated COVID-19 disease in late December 2019 has led to a global pandemic. At the time of writing, there have been 150 000 confirmed cases and 3500 deaths. Apart from the morbidity and mortality directly related to COVID-19 cases, society has had to also cope with complex political and economic repercussions of this disease.

At present, and despite pressing need for therapeutic intervention, management of patients with COVID-19 is entirely supportive. Despite the majority of patients experiencing a mild respiratory illness a subgroup, and in particular those with pre-existing cardiovascular disease, will experience severe illness that requires invasive cardiorespiratory support in the intensive care unit.

Furthermore, the severity of COVID-19 disease (as well as the likelihood of progressing to severe disease) appears to be in part driven by direct injury to the cardiovascular system. Analysis of data from two recent studies confirms a significantly higher likelihood of acute cardiac injury in patients who have to be admitted to intensive care for the management of COVID-19 disease.

The exact type of acute of cardiac injury that COVID-19 patients suffer remains unclear. There is however mounting evidence that heart attack like events are responsible. Tests ordinarily performed to definitely assess for heart attacks will not be possible in very sick COVID-19 patients. Randomising patients to cardioprotective medicines will help us understand the role of the cardiovascular system in COVID-19 disease. It will also help us determine if there is more we can do to treat these patients.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Prospective Multicentre Randomised Controlled Trial
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE COVID-19
Intervention  ICMJE
  • Drug: Aspirin 75mg
    • If patient not on aspirin, add aspirin 75mg once daily unless contraindicated.
  • Drug: Clopidogrel 75mg
    • If patient not on clopidogrel or equivalent, add clopidogrel 75mg once daily unless contraindicated
  • Drug: Rivaroxaban 2.5 MG
    • If patient not on an anticoagulation, add rivaroxaban 2.5mg bd unless contraindicated
    • If patient on DOAC then change to rivaroxaban 2.5mg unless contraindicated
  • Drug: Atorvastatin 40mg
    • If patient not on a statin, add atorvastatin 40mg once daily unless contraindicated
  • Drug: Omeprazole 20mg
    • If patient not on a proton pump inhibitor, add omeprazole 20mg once daily.
Study Arms  ICMJE
  • Experimental: Active Arm
    Interventions:
    • Drug: Aspirin 75mg
    • Drug: Clopidogrel 75mg
    • Drug: Rivaroxaban 2.5 MG
    • Drug: Atorvastatin 40mg
    • Drug: Omeprazole 20mg
  • No Intervention: Control Arm
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 1, 2020)
3170
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 30, 2021
Estimated Primary Completion Date March 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Confirmed COVID-19 infection
  2. Age =/>40 or diabetes or known coronary disease or hypertension
  3. Requires hospital admission for further clinical management.

Exclusion Criteria:

  1. Clear evidence of cardiac pathology needing ACS treatment.
  2. Myocarditis with serum Troponin > 5000
  3. Bleeding risk suspected e.g. recent surgery, history of GI bleed, other abnormal blood results (Hb<10g/dl, Plts <100, any evidence of DIC)
  4. Study treatment may negatively impact standard best care (physician discretion).
  5. Unrelated co-morbidity with life expectancy <3 months.
  6. Pregnancy.
  7. Age <18 years and >85 years.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Alena Marynina, BSc, MSc 07776 224520 alena.marynina@nhs.net
Contact: Clare Coyle, BMBCh, BA, MRCP 07985 352148 c.coyle@imperial.ac.uk
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04333407
Other Study ID Numbers  ICMJE 20HH5868
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: No individual participant data will be shared with other researchers or organisations. Anonymised data might be shared with other research organisations
Responsible Party Imperial College London
Study Sponsor  ICMJE Imperial College London
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Prapa Kanagaratnam, FRCP, PhD Imperial College Healthcare NHS Trust
PRS Account Imperial College London
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP