| CTRI Number |
CTRI/2025/02/080038 [Registered on: 07/02/2025] Trial Registered Prospectively |
| Last Modified On: |
07/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Study on safety and effectiveness, and usage of two drugs used for managing blood-pressure |
|
Scientific Title of Study
|
An Observational, Parallel arm study to assess safety, clinical utilization and effectiveness of Bisoprolol or Metoprolol in stable coronary Artery Disease with reduced ejection fraction (CADBIS Study) |
| Trial Acronym |
CADBIS Study |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| TPL2404480 Version-1.0, Date 06/05/2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Arun Kumar G |
| Designation |
MD, DM (Cardiology) |
| Affiliation |
Medical Trust Hospital |
| Address |
Medical Trust Hospital, Mahatma Gandhi Road, Pallimukku, Kochi, Ernakulam, Kerala 682016
Ernakulam
KERALA
682016
India |
| Phone |
9496157468 |
| Fax |
|
| Email |
arunkumargopalakrishnapillai@proton.me |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Krishnaprasad K |
| Designation |
General Manager - Medical Strategic Affairs (India,RoW) |
| Affiliation |
Torrent Pharmaceuticals Ltd. |
| Address |
Torrent Pharmaceuticals Ltd., Ashram Road - Navrangpura
Ahmadabad
GUJARAT
380009
India |
| Phone |
07069000572 |
| Fax |
|
| Email |
krishnaprasadkorukonda@torrentpharma.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rathish Nair |
| Designation |
Assistant General Manager - Medical Strategic Affairs |
| Affiliation |
Torrent Pharmaceuticals Ltd. |
| Address |
Torrent Pharmaceuticals Ltd., Ashram Road - Navrangpura,
Ahmadabad
Ahmadabad
GUJARAT
380009
India |
| Phone |
07069000560 |
| Fax |
|
| Email |
RathishNair@TorrentPharma.com |
|
|
Source of Monetary or Material Support
|
| Torrent Pharmaceuticals Ltd., Ashram Road - Navrangpura, Ahmedabad, GUJARAT-380009, India |
|
|
Primary Sponsor
|
| Name |
Torrent Pharmaceuticals Ltd. |
| Address |
Torrent Pharmaceuticals Ltd., Ashram Road - Navrangpura, Ahmedabad, GUJARAT-380009, India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Arun Kumar G |
Medical Trust Hospital |
Medical Trust Hospital, Mahatma Gandhi Road, Pallimukku, Kochi, Ernakulam, Kerala 682016
Ernakulam
KERALA |
9496157468
arunkumargopalakrishnapillai@proton.me |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee- The Madras Medical Mission |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I251||Atherosclerotic heart disease of native coronary artery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Male or Female patients 18 to 65 years.
2. An echocardiogram within six months prior inclusion which indicated an abnormally functioning or dilated left ventricle with (No angina, No NYHA class III or class IV).
3. Stable CAD cases confirmed with coronary angiography
4. Ejection fraction less than 40 percent with or without Atrial Fibrillation.
5. Known CAD cases with any comorbid risk factors.
6. Not on Beta Blockers therapy.
7. Patient willing to enroll for the study.
8. Patient on background medical therapy or no therapy. |
|
| ExclusionCriteria |
| Details |
1. Hypersensitivity to Bisoprolol or Metoprolol.
2. Patients with mildly reduced or preserved ejection fraction. (greater than 40 percent)
3. Having a baseline heart rate less than 60 per min (sinus bradycardia).
4. Cardiogenic shock.
5. Second or third degree AV block.
6. Sick sinus syndrome.
7. Hepatic enzyme elevation X3 ULN.
8. For women only currently pregnant (confirmed with positive pregnancy test) or breastfeeding.
9. Stroke during last 30 days before enrolment.
10. Thromboembolic complications or thrombosis within 14 days before enrollment.
11. Use of psychoactive drugs. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Mean change in LVEF after 8 and 24 weeks of treatment.
2. Change in Blood Pressure (SBP & DBP) at 8 and 24 weeks from baseline.
3. Mean change in Heart rate (HR) from baseline to 8 and 24 weeks follow-up. |
At 8 weeks and 24 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mean change in LV volume (End Diastolic Volume or Preload) |
At 8 weeks and 24 weeks |
| Mean change in LDL-C, HDL-C and Triglycerides level after 8 and 24 weeks from baseline |
At 8 weeks and 24 weeks |
| Mean change in comorbid risk factors (Dyslipidemia or HTN or T2DM) |
At 8 weeks and 24 weeks |
| Proportion of participants with treatment emergent adverse event during observation period. |
At 8 weeks and 24 weeks |
| Concomitant medicine prescribing trend for CAD |
At 8 weeks and 24 weeks |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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
|
N/A |
|
Date of First Enrollment (India)
|
17/02/2025 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a Prospective, parallel arm, observational clinical study to study the impact of Bisoprolol or Metoprolol in stable coronary Artery Disease with reduced ejection fraction.
Total 80 patients will be enrolled in this study.
Study drug: Bisoprolol 2.5 or 5 mg and Metoprolol 25 or 50 mg |