Status:
TERMINATED
The CHORAL Flow Study
Lead Sponsor:
Imperial College London
Conditions:
Coronary Artery Disease
Atherosclerosis
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
CHORAL Flow is a randomised, double blinded, placebo-controlled trial of the effects of evolocumab on coronary flow at 12 weeks.
Detailed Description
Evolocumab is a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor which has been shown in the Fourier Trial to reduce major cardiovascular events in statin-treated patients with raised L...
Eligibility Criteria
Inclusion
- Patients aged between 18 and 80 years, with a clinical indication for coronary angiography and:
- willing to provide consent: Provide written (signed and dated) informed consent and be capable of understanding the study and co-operating with treatment and follow-up.
- raised levels of fasting (\>9h) LDL-cholesterol (≥2mmol/L) either on optimal statin therapy (90% of overall sample) or intolerants to statins (restricted to 10% of overall sample). Optimal statin therapy will be defined as at least 4 weeks of atorvastatin 40mg or more, with no change in statin dose during this period.
- at least one other risk factor for vascular disease or established vascular disease.
- willing and able to use a highly effective method of contraception from screening until 15 weeks after the last dose of IP if a woman of childbearing potential.
Exclusion
- Patients unable or unwilling to provide written informed consent;
- Patients unable to undergo cardiac catheterisation;
- Patients with contraindication to adenosine (severe asthma, second or third degree atrioventricular block, heart rate lower than 40/min at rest, previous formal diagnosis of long QT syndrome, acute decompensated heart failure, severe hypotension, advanced (stage IV) or decompensated chronic obstructive pulmonary disease (COPD);
- Uncontrolled hypertension (systolic BP \>180mmHg or DBP \>110mmHg, despite ongoing therapy);
- Clinical heart failure NYHA class III/IV or Ejection Fraction on imaging modality (Echo, MRI) \<40%;
- Severe valvular heart disease;
- Severe (\>95% diameter) epicardial coronary stenosis;
- Recent (last 12 months) clinically significant cerebrovascular event (including ischaemic or haemorrhagic events);
- End-stage renal failure (eGFR \< 30 mL/min/1.73m2);
- Advanced liver disease, defined as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 3x ULN
- Current use of PCSK9 inhibitor;
- Malignancy with life expectancy \<1y;
- Currently or within last 3 months enrolled on another CTIMP;
- Known allergy to evolocumab or incipients;
- Women of childbearing potential who are unwilling or unable to use a highly effective method of contraception from screening until 15 weeks after the last dose of IP.
- Subject is pregnant or breast feeding or planning to become pregnant or to breastfeed during screening, during treatment with IP and/ or within 15 weeks after the end of treatment with IP.
Key Trial Info
Start Date :
September 11 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 27 2022
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04073134
Start Date
September 11 2019
End Date
May 27 2022
Last Update
August 6 2024
Active Locations (1)
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1
Imperial College NHS Foundation Trust
London, United Kingdom, W12 0HS