Study assessing impact of additional reduction of bad cholesterol on heart related diseases with AMG 145 when used in combination with cholesterol lowering medications

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2014/01/004324
• Date of registration: 17-01-2014
• Prospective Registration: Yes
• Primary sponsor: Amgen Technology Pvt Ltd
• Public title: Study assessing impact of additional reduction of bad cholesterol on heart related diseases with AMG 145 when used in combination with cholesterol lowering medications
• Scientific title: A Double-blind, Randomized, Placebo-controlled, Multicenter Study Assessing the Impact of Additional LDL-Cholesterol Reduction on Major Cardiovascular Events When evolocumab is Used in Combination With Statin Therapy In Patients With Clinically Evident Cardiovascular Disease - FOURIER (Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk)
• Date of first enrolment: 25-04-2014
• Target sample size: 27500
• Recruitment status: Completed
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=8147
• Study type: Interventional
• Study design: Randomized, Parallel Group, Placebo Controlled Trial; Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
• Phase: Phase 3

Countries of recruitment

Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czech Republic, Democratic People's Republic of Korea, Denmark, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Latvia, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Philippines, Poland, Portugal, Romania, Russian Federation, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, United Kingdom, United States of America

Contacts

• Name: Sagar Patil
• Affiliation: Amgen Technology Pvt Ltd

• Name: Dr Veena Jaguste
• Affiliation: Amgen Technology Pvt Ltd

Key inclusion & exclusion criteria

Inclusion criteria: 1. Male or female >= 40 to <= 85 years of age {Note: For India the upper age will be limited to 80yrs as per DCGI approval letter}

2. History of clinically evident cardiovascular disease at high risk for a recurrent event

3. Fasting LDL-C >= 70 mg/dL (>= 1.8 mmol/L) ) or non-HDL-C >= 100 mg/dL ( > 2.6 mmol/L)

4. Fasting triglycerides <= 400 mg/dL (4.5 mmol/L)


Exclusion criteria: 1. NYHA class III or IV, or last known left ventricular ejection fraction less than 30%

2. Uncontrolled hypertension

3. Uncontrolled or recurrent ventricular tachycardia

4. Untreated hyperthyroidism or hypothyroidism

5. Homozygous familial hypercholesterolemia

6. LDL or plasma apheresis





Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: null- Dyslipidemia Health Condition 2: I519- Heart disease, unspecified

Intervention(s)

Intervention1: Evolocumab (AMG 145) and Effective statin therapy: Experimental: Arm 1 Evolocumab (AMG 145) will be administered at 1 of 2 regimens: Q2W (1 prefilled AI/Pen injection) or QM (3 prefilled AI/Pen injections or 1 Personal Injector injection) plus effective statin
Effective statin therapy defined as greater than or equal to atorvastatin 20 mg or an equivalent statin
for duration of up to approximately 5 years

Control Intervention1: Placebo and Effective statin therapy: Placebo Comparator: Arm 2
Placebo will be administered at 1 of 2 regimens:
Placebo SC Q2W (1 prefilled AI/Pen injection) or
Placebo SC QM (3 prefilled AI/Pen injections or 1 Personal Injector injection)

Effective statin therapy defined as greater than or equal to atorvastatin 20 mg or an equivalent statin for duration of up to approximately 5 years

Primary Outcome(s)

The primary endpoint is the time to cardiovascular death, myocardial infarction,

hospitalization for unstable angina, stroke, or coronary revascularization, whichever

occurs first. (Note: The primary endpoint includes all adjudicated strokes, ischemic and

hemorrhagic.)Timepoint: The study is event driven and will conclude when at least 1630 subjects have experienced an event adjudicated as qualifying for the key secondary endpoint

Secondary Outcome(s)

â?¢ time to cardiovascular death, myocardial infarction, or stroke, whichever occurs first

Other secondary endpoints are:

â?¢ time to cardiovascular death

â?¢ time to death by any cause

â?¢ time to first myocardial infarction

â?¢ time to first stroke

â?¢ time to first coronary revascularization

â?¢ time to cardiovascular death or first hospitalization for worsening heart failure,

whichever occurs first

â?¢ time to ischemic fatal or non-fatal stroke or TIA, whichever occurs firstTimepoint: The study is event driven and will conclude when at least 1630 subjects have experienced an event adjudicated as qualifying for the key secondary endpoint

Secondary ID(s)

20110118 (Superseding Protocol Amendment 6, dt.20 Oct 2015)

Source(s) of Monetary Support

Amgen Inc.

Ethics review

Status: Approved
Approval date: 05/06/2013
Contact:

Institutional Ethics Committee, King Georges Medical College - Dr. Sudanshu Kumar Dwivedi

Status: Approved
Approval date: 09/11/2015
Contact:

Ethics Committee of Care Institute of Medical Science - Dr. Keyur Parikh

Status: Approved
Approval date: 18/11/2015
Contact:

Ethics Committee - SAL Hospital and Medical Institute - Dr. Anil Jain

Status: Approved
Approval date: 20/11/2015
Contact:

Institutional Ethics Committee Cardiac and Multispeciality Hospital Private Limited - Dr Ramesh

Status: Approved
Approval date: 23/11/2015
Contact:

AMC MET Ethics Committee - Dr. Sunil Tyagi

Status: Approved
Approval date: 24/11/2015
Contact:

Institutional Ethics Committee, Lokmanya Tilak Municipal Medical College - Dr. Ajay Kumar Mahajan

Status: Approved
Approval date: 07/12/2015
Contact:

Niramaya Hospital Ethics Committee - Dr. Abhijeet Joshi

Status: Approved
Approval date: 02/01/2016
Contact:

Institutional Ethics Committee, Department of Pharmacology, Government Medical College -Dr. Vinod Khandait

Status: Approved
Approval date: 04/01/2016
Contact:

Ethics Committee of Shree Hospital - Dr Govind Kulkarni

Status: Approved
Approval date: 04/01/2016
Contact:

Institutional Ethics Committee, Mysore Medical College & Research Institute and Associated Hospitals Dr Ravishankar Govinda

Status: Approved
Approval date: 20/01/2016
Contact:

Institutional Ethics Committee on Human Research - Dr Mahendra Parmar

Status: Approved
Approval date: 21/01/2016
Contact:

Institutional Ethics Committee, Maulana Azad Medical College - Dr VimalMehta

Status: Approved
Approval date: 21/01/2016
Contact:

Institutional Ethics Committee, Maulana Azad Medical College - Dr. Sunita Aggrawal

Status: Approved
Approval date: 02/02/2016
Contact:

Institutional Ethics Committee, Topiwala National Medical College & B.Y.L. Nair Charitable Hospital - Dr Girish Rajadhyaksha

Status: Approved
Approval date: 15/02/2016
Contact:

Ethics Committee of KLE University Dr. Veerappa Kothiwale

Status: Approved
Approval date: 17/02/2016
Contact:

Medanta Institutional Ethics Committee - Dr Vijay Chopra

Status: Approved
Approval date: 10/03/2016
Contact:

Institutional Ethics Committee B.J.Medical College & Civil Hospital -Dr Solanki

Status: Approved
Approval date: 21/02/2017
Contact:

O&P Institutional Ethics Committee - Dr Rahul Pai

Results

• Date Completed: 08/10/2016