Prophylactic Effect of Nirmatrelvir/Ritonavir and Ursodeoxycholic Acid on Reducing Complications After Cardiac Surgery

Cardiac Surgery Clinical Trial

— PEP  

Official title:

Prophylactic Effect of Nirmatrelvir/Ritonavir and Ursodeoxycholic Acid on Reducing Complications After Cardiac Surgery During COVID-19 Pandemics: A Prospective, Randomized Controlled, Multicenter Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05690646
• Other study ID #: NCRC2023001
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: January 28, 2023
• Est. completion date: January 6, 2026

Study information

• Verified date: January 2023
• Source: China National Center for Cardiovascular Diseases
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Prophylactic effect of nirmatrelvir/ritonavir and ursodeoxycholic acid on reducing complications after cardiac surgery during covid-19 pandemics (the pep trial) is a multicenter, randomized controlled trial. The aim of the pep trial is to investigate whether prophylactic use of nirmatrelvir/ritonavir and ursodeoxycholic could reduce complications after cardiac surgery.

Description:

After informed consent, four centers and 436 eligible admissions will be recruited. Eligible patients would be randomized (1:1:1:1) to nirmatrelvir/ritonavir group (nirmatrelvir 300mg q12h and ritonavir 100 mg q12h for 5 days), ursodeoxycholic acid group (ursodeoxycholic acid group, 15mg/kg/day bid for5 days), combination group (nirmatrelvir/ritonavir and ursodeoxycholic acid for 5days) and control group.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 491
• Est. completion date: January 6, 2026
• Est. primary completion date: March 24, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age =18 years
• COVID-19 nucleic acid test or antigen test positive history, without symptom or recover from COVID-19 related symptoms =2 weeks
• Receive open-chest cardiac surgery
• COVID-19 nucleic acid test and antigen test negative and no signs of pneumonia in chest CT
• Patients with written informed consent.

Exclusion Criteria:

• Emergency surgery
• eGFR =30ml/min
• Severe liver dysfunction
• Contraindication to nirmatrelvir/ritonavir or ursodeoxycholic acid

Related Conditions & MeSH terms

• Cardiac Surgery

Intervention

Drug:
• Nirmatrelvir/ritonavir
nirmatrelvir 300mg q12h and ritonavir 100 mg q12h for 5 days
• Ursodeoxycholic acid
ursodeoxycholic acid 15mg/kg/day bid for5 days

Locations

Country	Name	City	State
China	Fuwai Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
China National Center for Cardiovascular Diseases

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MACCE	All-cause mortality, myocardial infarction, stroke, moderate to severe acute kidney injury, and COVID-19 pneumonia	30 days after surgery or during hospitalization
Secondary	All-cause mortality	All-cause mortality	30 days after surgery or during hospitalization
Secondary	Rate of Myocardial infarction	new onset of myocardial infarction	30 days after surgery or during hospitalization
Secondary	Rate of Stroke	new onset of stroke	30 days after surgery or during hospitalization
Secondary	Rate of Moderate to severe acute kidney injury	new onset of moderate to severe acute kidney injury	30 days after surgery or during hospitalization
Secondary	Rate of COVID-19 pneumonia	new onset of COVID-19 pneumonia	30 days after surgery or during hospitalization
Secondary	Rate of Cardiogenic death	Cardiogenic death	30 days after surgery or during hospitalization
Secondary	Rate of Severe pneumonia	new onset of Severe pneumonia	30 days after surgery or during hospitalization
Secondary	Rate of Ventilation =24h	Ventilation =24h after surgery	30 days after surgery or during hospitalization
Secondary	Rate of Pulmonary embolism	new onset of Pulmonary embolism	30 days after surgery or during hospitalization
Secondary	Rate of Re-operation for bleeding	Re-operation for bleeding after primary surgery	30 days after surgery or during hospitalization
Secondary	All-cause mortality	All-cause mortality	1 year after surgery
Secondary	Rate of Myocardial infarction	new onset of Myocardial infarction	1 year after surgery
Secondary	Rate of Stroke	new onset of Stroke	1 year after surgery
Secondary	Rate of Renal insufficiency	new onset of Renal insufficiency	1 year after surgery
Secondary	Rate of Re-hospitalization for respiratory disease	Re-hospitalization for respiratory disease	1 year after surgery
Secondary	Rate of Cardiogenic re-hospitalization	Cardiogenic re-hospitalization	1 year after surgery