| CTRI Number |
CTRI/2024/05/067550 [Registered on: 17/05/2024] Trial Registered Prospectively |
| Last Modified On: |
16/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare rosuvastatin which is administered daily in one group and on alternate days in the other group comparing the improvement of blood lipid profile and to compare the side effects |
|
Scientific Title of Study
|
A comparative study to evaluate efficacy and safety of daily versus alternate day rosuvastatin therapy in patients with dyslipidemia |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Laxminarayana Kamath |
| Designation |
Assistant Professor |
| Affiliation |
Bangalore Medical College and Research Institute |
| Address |
Department of Pharmacology, Bangalore medical college and research institute, Fort, Krishna Rajendra Rd, Kalasipalya, Bengaluru
Bangalore
KARNATAKA
560002
India |
| Phone |
9241716884 |
| Fax |
|
| Email |
drlmnkamath@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Laxminarayana Kamath |
| Designation |
Assistant Professor |
| Affiliation |
Bangalore Medical College and Research Institute |
| Address |
Department of Pharmacology, Bangalore medical college and research institute, Fort, Krishna Rajendra Rd, Kalasipalya, Bengaluru
Bangalore
KARNATAKA
560002
India |
| Phone |
9241716884 |
| Fax |
|
| Email |
drlmnkamath@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr George T Varghese |
| Designation |
Post graduate |
| Affiliation |
Bangalore Medical College and Research Institute |
| Address |
Department of Pharmacology, Bangalore medical college and research institute, Fort, Krishna Rajendra Rd, Kalasipalya, Bengaluru
Bangalore
KARNATAKA
560002
India |
| Phone |
8073225710 |
| Fax |
|
| Email |
drgeorgetv94@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bangalore medical college and research institute, Bangalore |
|
|
Primary Sponsor
|
| Name |
George T Varghese |
| Address |
Bangalore Medical College and Research Institute, Fort, Krishna Rajendra Road, Bangalore - 560002 |
| Type of Sponsor |
Other [self sponsor] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr George T Varghese |
Bangalore Medical College & Research Institute Super Speciality Hospital |
Department of Cardiology, Second floor, Bangalore Medical College & Research Institute Super Speciality Hospital(Pradhana Mantri Swasthya Suraksha Yojana), Fort, Krishna Rajendra Road, Bangalore - 560002
Bangalore
KARNATAKA |
8073225710
drgeorgetv94@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bangalore medical college and research institute ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E785||Hyperlipidemia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Rosuvastatin |
alternate day administration of 10 mg orally once at night to adult patients with dyslipidemia for 6 weeks |
| Comparator Agent |
Rosuvastatin |
daily administration of 10 mg orally once at night to adult patients with dyslipidemia for 6 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients willing to give written informed consent.
2. Patients aged more than 18 and less than or equal to 65 years.
3. Treatment naive patients of dyslipidemia in low to moderate risk group as diagnosed by NCEP ATP III guidelines |
|
| ExclusionCriteria |
| Details |
1. Patients unwilling to give written informed consent.
2. Patients with a documented history of acute coronary syndrome, cerebrovascular accident, on-going angina.
3. Pregnant and lactating mothers.
4. Patients on co-existing medication which aggravate statin myopathy. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Percentage reduction in LDL-C
2. Changes in other lipid markers like total cholesterol, triglycerides, HDL-C
|
6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Number and severity of adverse events reported by the patient at any time during the study. |
6 weeks |
|
|
Target Sample Size
|
Total Sample Size="96"
Sample Size from India="96"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
15/06/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Dyslipidemia
has been closely linked to the pathophysiology of ASCVD (Atherosclerotic
cardiovascular disease).Worldwide an estimated 17.7 million
people died from ASCVD in 2018, representing 31% of all global deaths. In India,
there has been an alarming increase in the prevalence of CVD over the past two
decades and accounts for 24% of all deaths among adults aged 25–69 years.
India is expected to contribute more than half the cases of ASCVD
globally in the next 15 years. Elevated plasma LDL cholesterol
(LDL-C) levels being a major modifiable risk factor for atherosclerosis
presents an important point of intervention in the primary prevention of ASCVD.
The
National Cholesterol Education Programme (NCEP) adult treatment panel (ATP) III
guidelines and American College of Cardiology/American Heart Association
(ACC/AHA) recommends statins as the first choice hypolipidemic drug which are
the most effective and best tolerated agents for treating dyslipidemia. When compared with other statins, rosuvastatin has low potential for drug-drug interactions,
is hepato-specific, hydrophilic and exhibits pleiotropic effects such as plaque
stabilization, anti-platelet aggregation, anti-atherogenic and anti-oxidant properties. Additionally, rosuvastatin
along with its long lasting active metabolites confer a much longer
hydroxy-methyl-glutaryl (HMG) CoA reductase inhibition of twenty five to thirty
hours which makes it effective even on the next day.
In spite of
many beneficial effects of statins, patients of lower socio-economic status may
discontinue long term daily statin therapy due to its prohibitive cost.
Additionally, some patients discontinue statin therapy secondary to adverse
effects such as myalgias, muscle cramps and weakness. Dosing a statin like
rosuvastatin on alternate day as opposed to a daily regimen may provide
significant lipoprotein changes while reducing common adverse effects at a more
affordable cost to the patient. In view of the limited body of
comparative studies between the two regimens, this study is undertaken to
compare the efficacy and safety of daily versus alternate day rosuvastatin
therapy in reduction of lipid parameters in treatment naïve patients of
dyslipidemia. |