| CTRI Number |
CTRI/2025/01/078948 [Registered on: 17/01/2025] Trial Registered Prospectively |
| Last Modified On: |
08/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Procedure] |
| Study Design |
Other |
|
Public Title of Study
|
A randomized trial comparing two strategies (pressure wire versus visual inspection) to identify
which blocked arteries should be opened with angioplasty in patients suffering a heart attack. |
|
Scientific Title of Study
|
A randomized trial of physiology-guided versus angiography-guided non-culprit lesion (NCL)
complete revascularization strategies and a large-scale observational study of Optical Coherence
Tomography in patients with acute myocardial infarction and multivessel coronary artery disease |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| COMPLETE-2, Version 1.0, Date 07/Mar/2023 |
Protocol Number |
| NCT05701358 |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mr Jamnadas Kushwaha |
| Designation |
Head- CT |
| Affiliation |
Raptim Research Pvt. Ltd. |
| Address |
A-242, T.T.C., Industrial Area, Mahape M.I.D.C., Navi Mumbai -
Thane
MAHARASHTRA
India
Thane
MAHARASHTRA
400710
India |
| Phone |
9819475207 |
| Fax |
|
| Email |
jamnadas.kushwaha@raptimresearch.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mr Jamnadas Kushwaha |
| Designation |
Head- CT |
| Affiliation |
Raptim Research Pvt. Ltd. |
| Address |
A-242, T.T.C., Industrial Area, Mahape M.I.D.C., Navi Mumbai -
Thane
MAHARASHTRA
India
MAHARASHTRA
400710
India |
| Phone |
9819475207 |
| Fax |
|
| Email |
jamnadas.kushwaha@raptimresearch.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Jamnadas Kushwaha |
| Designation |
Head- CT |
| Affiliation |
Raptim Research Pvt. Ltd. |
| Address |
A-242, T.T.C., Industrial Area, Mahape M.I.D.C., Navi Mumbai -
Thane
MAHARASHTRA
India
MAHARASHTRA
400710
India |
| Phone |
9819475207 |
| Fax |
|
| Email |
jamnadas.kushwaha@raptimresearch.com |
|
|
Source of Monetary or Material Support
|
| Population Health Research Institute (PHRI) 237 Barton Street East Hamilton, Ontario, Canada
L8L 2X2 |
|
|
Primary Sponsor
|
| Name |
Population Health Research Institute (PHRI) |
| Address |
237 Barton Street East Hamilton, Ontario, Canada L8L 2X2 |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NA |
NA |
| Raptim Research Pvt Ltd |
A-242,A-226, TTC Industrial Area, Near Mahape Depot,Mahape MIDC, Navi Mumbai – 400710, India |
|
|
Countries of Recruitment
|
Australia
Austria
Canada
Czech Republic
Denmark
Finland
Germany
Hungary
India
Italy
Mexico
Netherlands
Norway
Poland
Serbia
South Africa
Spain
Sweden
United Kingdom
United States of America |
Sites of Study
Modification(s)
|
| No of Sites = 12 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sengottuvelu G |
Apollo Hospital |
Greams Lane, 21, Greams Rd, Thousand Lights West, Thousand Lights, 600006
Chennai
TAMIL NADU |
9841430999
drgseng@gmail.com |
| Dr Sarita Rao |
Apollo Rajshree Hospitals |
Indore, Scheme No. 74 C, Sector D, Vijay Nagar, 452010, India
Indore
MADHYA PRADESH |
8959907706
saritarosh@yahoo.com |
| Dr Deepak Davidson |
Caritas Hospital |
Thellakom, 686630
Kottayam
KERALA |
9447216959
deepakdavidson@yahoo.com |
| Dr Ajay Swami |
KIMS Hospital |
KIMS Hospital, 1-8-31/1, 15 floor, clinical research department (Cardiology), Minister Road, Krishna Nagar Colony, Begumpet, Secunderabad - 500003, Telangana, INDIA.
Hyderabad
TELANGANA |
9650097303
ajayswamy@rediffmail.com |
| Dr Rony Mathew |
Lisie Hospital |
Department of cardiology, Fifth floor, St Antonys Block Kochi-682018, India.
Ernakulam
KERALA
Ernakulam
KERALA |
9846097812
drronymathew@yahoo.com |
| Dr Praveen Chandra |
Medanta Medicity |
Sector-38, 122001, India
Gurgaon
HARYANA |
9810125370
praveen.chandra@medanta.org |
| Dr Rajneesh Kapoor |
Medanta Medicity |
Sector-38, 122022, India
Gurgaon
HARYANA |
9971991740
rajneesh.kapoor@medanta.org |
| Dr Sharath Reddy Annam |
Medicover Hospitals |
Medicover Hospitals, Department of cardiology, Room no 59, second floor, Opp Cyber Gate Way, HUDA techno enclave, Hitech city, Hyderabad-500081, Telengana, India
Hyderabad
TELANGANA |
9440087532
drsharathdm@gmail.com |
| Dr Prathap Kumar N |
Meditrina Hospital Pvt. Ltd, |
Cathlab department , first floor, Kollam - Ayoor Road, Bypass Road, Ayathil, 691021, India
Kollam
KERALA
Kollam
KERALA |
7025222244
prathapndr@gmail.com |
| Dr Selvamani S |
Meenakshi Mission Hospital & Research Center |
Lake Area, Melur Main Rd, 625107
Madurai
TAMIL NADU |
9842158868
maniselvacardio@gmail.com |
| Dr Sanjeeb Roy |
Rukmani Birla Hospital |
Department of cardiology, A unit of CMRI, Gopalpura bypass road, Gopalpura,302018, India.
Jaipur
RAJASTHAN |
9829644459
roysanjeeb@gmail.com |
| Dr Ajit Mullasari |
The Madras Medical Mission |
The Madras Medical Mission, Room No.1, L-floor, institute of cardiovascular disease, 4-A, Dr. J J Nagar, Mogappair, Chennai- 600037, India
Chennai
TAMIL NADU |
4426565961
icvddoctors@mmm.org.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 12 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Meenakshi Mission Hospital and Research Center |
Approved |
| Institutional Ethics Committee |
Approved |
| Institutional Ethics Committee Biomedical Research, Apollo Hospitals |
Approved |
| Institutional Ethics Committee, Apollo Rajshree Hospitals |
Approved |
| Institutional Ethics Committee, Caritas Hospital |
Approved |
| Institutional Ethics Committee, Medicover Hospital |
Approved |
| Institutional Ethics Committee, Rukmani Birla Hospital |
Approved |
| Institutional Ethics Committee, The Madras Medical Mission |
Approved |
| KIMS Ethics Committee |
Approved |
| Medanta Institutional Ethics Committee |
Approved |
| Meditrina Ethics Committee |
Approved |
| The Medanta Institutional Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I21||Acute myocardial infarction, (2) ICD-10 Condition: I251||Atherosclerotic heart disease of native coronary artery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NA |
NA |
| Intervention |
Physiology-guided versus angiography-guided non-culprit lesion (NCL)complete revascularization strategies |
Eligible patients will be randomly allocated (using concealed central randomization) to either physiology-guided complete revascularization or angiography-guided complete revascularization.
Total duration-01 Days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients presenting with STEMI or type 1 NSTEMI and within 72 hours of successful culprit-lesion PCI
2. Residual coronary artery disease defined as at least 1 additional non-infarct related coronary artery stenosis (ie, non-culprit lesion) that meets all of the following criteria:
a) Amenable to successful treatment with PCI
b) At least 50% diameter stenosis by visual estimation
c) At least 2.5 mm in diameter
3. Planned complete revascularization strategy for qualifying myocardial infarction |
|
| ExclusionCriteria |
| Details |
1. Planned or prior coronary artery bypass graft (CABG) surgery
2. Inability to clearly identify a culprit lesion for index STEMI or NSTEMI based on angiographic appearance and/or ECG changes and/or regional wall motion abnormalities
3. Prior PCI of a non-culprit lesion in a different vessel from the culprit lesion within 45 days of randomization
4. Planned medical treatment of all qualifying non-culprit lesions (i.e., no PCI)
5. Presence of severe non-culprit-lesion stenosis with reduced epicardial flow (TIMI flow less than equal 2) or more than 90% visual diameter stenosis
6. Presence of a chronic total occlusion (CTO) if it is the only qualifying non-culprit lesion (patients with a CTO plus additional qualifying non-culprit lesions are eligible)
7. The only qualifying non-culprit lesion is in the same vessel territory as the culprit lesion
8. Baseline STEMI or NSTEMI was due to a suspected non-atherothrombotic mechanism such as type 2 MI (supply-demand mismatch), e.g. spontaneous coronary artery dissection or coronary artery embolism
9. Non-cardiovascular co-morbidity with expected life expectancy less 2 years
10. Any other medical, geographic, or social factor (i.e., lack of access to transportation for clinical follow-up visits, inflexible schedule conflicting with follow-up visits) making study participation impractical or precluding 5 year follow-up |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Efficacy: Time to first occurrence of the composite of CV death, new MI or ischemia-driven revascularization (IDR).
Safety: Time to first occurrence of the composite of clinically significant bleeding, stroke, stent thrombosis or contrast-associated acute kidney injury. |
5 Years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Time to first occurrence of the composite of CV death or new MI.
2. Net clinical outcome: Time to first occurrence of the composite of CV death, new MI, clinically significant bleeding, stroke, stent thrombosis or contrast associated
acute kidney injury. |
5 Years |
|
|
Target Sample Size
|
Total Sample Size="5100"
Sample Size from India="1000"
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)
|
31/01/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
22/06/2023 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="5"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
In patients with acute ST-segment elevation myocardial infarction (STEMI) or non-ST-segment elevation myocardial infarction (NSTEMI) and multivessel coronary artery disease (CAD) who have undergone successful culprit lesion Percutaneous Coronary Intervention (PCI): 1. To determine whether a strategy of physiology-guided complete revascularization is nonâ€inferior to a strategy of angiographyâ€guided complete revascularization on the efficacy composite outcome of cardiovascular (CV) death, new myocardial infarction (MI) or ischemiaâ€driven revascularization (IDR). If non-inferiority is established, superiority of the physiology-guided strategy will be tested.
2. To determine whether a physiology-guided complete revascularization strategy is superior to an angiography-guided complete revascularization strategy in reducing the safety composite outcome of clinically significant bleeding, stroke, stent thrombosis or contrast-associated acute kidney injury. |