CTRI

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CTRI Number

CTRI/2024/07/070189 [Registered on: 08/07/2024] Trial Registered Prospectively

Last Modified On:

23/08/2025

Post Graduate Thesis

Type of Trial

Interventional

Type of Study

Other (Specify) [Routine Invasive Strategy Based On PCI with Stenting]

Study Design

Randomized, Parallel Group, Active Controlled Trial

Public Title of Study

Role of heart intervention (e.g, heart vessel ballooning and stenting) in heart attack patients presenting late between 12-72 hours of chest pain onset

Scientific Title of Study

Routine Invasive Vs Ischemia Driven Strategy In Patients With ST-Segment-Elevation Myocardial Infarction Presenting Between 12-72 Hours Of Symptom Onset (LATECOMER TRIAL)

Trial Acronym

LATECOMER Trial

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr S Ramakrishnan
Designation	Professor
Affiliation	AIIMS New Delhi
Address	Room No 29 7th Floor C N Center AIIMS New Delhi South DELHI 110029 India
Phone	9818186179
Fax
Email	ramaaiims@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Nirmal Ghati
Designation	Assistant Professor
Affiliation	AIIMS New Delhi
Address	Room No 11 8th Floor C N Center AIIMS New Delhi South DELHI 110029 India
Phone	9013860076
Fax
Email	nirmal.cmc@gmail.com

Details of Contact Person
Public Query

Name	Dr Nirmal Ghati
Designation	Assistant Professor
Affiliation	AIIMS New Delhi
Address	Room No 11 8th Floor C N Center AIIMS New Delhi DELHI 110029 India
Phone	9013860076
Fax
Email	nirmal.cmc@gmail.com

Source of Monetary or Material Support

Indian Council of Medical Research

Primary Sponsor

Name	Indian Council of Medical Research
Address	V. Ramalingaswami Bhawan, P.O. Box No. 4911, Ansari Nagar, New Delhi - 110029, India
Type of Sponsor	Government funding agency

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 12
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Ramachandra Barik	All India Institute of Medical Sciences, Bhubaneshwar	H.O.D. Office, Department of Cardiology, AIIMS, Bhubaneshwar, Sijua, Patrapada Baleshwar ORISSA	9491634156 cardioramachandra@gmail.com
Dr Surender Deora	All India Institute of Medical Sciences, Jodhpur	Room No 436, OPD 4th Floor, C - Block, Department of Cardiology, AIIMS, Basni Phase 2 Jodhpur RAJASTHAN	8003996715 drsdeora@gmail.com
Dr S Ramakrishnan	All India Institute of Medical Sciences, New Delhi	Room No. 29, 7th Floor, C. N. Center, AIIMS South DELHI	9818186179 ramaaiims@gmail.com
Dr Bishav Mohan	Dayanand Medical College and Hospital Ludhiana	1st Floor, Hero DMC Heart Institute, Tagore Nagar, Civil Lines Ludhiana PUNJAB	9876741158 bishav_68@yahoo.co.in
Dr Mohit D Gupta	Govind Ballabh Pant Hospital	Room No 125, Department Of Cardiology, Academic Bock, 1, Jawaharlal Nehru Marg, 64 Khamba, Raj Ghat South DELHI	9810121311 drmohitgupta@yahoo.com
Dr Sanjeev Astora	Indira Gandhi Medical College and Hospital	Room No 308, 3rd Floor, Department of Cardiology, Indira Gandhi Medical College and Hospital Shimla HIMACHAL PRADESH	9418080804 dr.sanjeev00@gmail.com
Dr Charan Lanjewar	KING EDWARD MEMORIAL HOSPITAL	4th Floor, CVTC Building, Department of Cardiology, Acharya Donde Marg, Pare Mumbai MAHARASHTRA	9769133740 Charanlanjewar@kem.edu
Dr Rishi Sethi	King Georges Medical University	Administrative Block, Department of Cardiology, KGMU, Shahmina Road, Chowk Lucknow UTTAR PRADESH	9838571770 drrishisethi1@gmail.com
Dr Justin Paul	Madras Medical College	Room No 2, Cardiovascular Research Unit, First Floor, Institute of Cardiology, Rajiv Gandhi Government General Hospital, Madras Medical College Chennai TAMIL NADU	9840071558 drjpheart@gmail.com
Dr Amit Malviya	North Eastern Indira Gandhi Regional Institute of Health and Medical Sciences	Room No 125, 1st Floor, Department of Cardiology, North Eastern Indira Gandhi Regional Institute of Health and Medical Sciences, NEIGRIHMS, Mawdiangdiang, Shillong East Khasi Hills MEGHALAYA	8794705698 dramit_malviya@rediffmail.com
Dr Sandeep Bansal	Safdarjung Hospital	Department of Cardiology, HOD. Office, Safdarjung Hospital, Ansari Nagar East, near to AIIMS Metro Station South DELHI	9810543368 drsbansal2000@yahoo.com
Dr Chandrabhan Meena	Sawai Man Singh Hospital	Research Wing, Department of Cardiology, SMS Medical College JLN Marg Jaipur RAJASTHAN	9414250934 drcbhan@gmail.com

Details of Ethics Committee

No of Ethics Committees= 12
Name of Committee	Approval Status
Ethicd Committee, Indira Gandhi Medical College, Shimla	Submittted/Under Review
Ethics Committee, S.M.S Medical college	Submittted/Under Review
Institute Ethics Commitee, AIIMS , Bhubaneswar	Submittted/Under Review
Institute Ethics Committee AIIMS Jodhpur	Submittted/Under Review
Institute Ethics Committee, King Georges Medical University	Submittted/Under Review
Institute Ethics Committee, MAIDS	Submittted/Under Review
InstituteEthicsCommitteeAIIMSNewDelhi	Approved
InstituteEthicsCommitteeSJH	Submittted/Under Review
Institutional Ethics Committee, Dayanand Medical College, Lundhiana	Submittted/Under Review
Institutional Ethics Committee, Madras Medical College, Chennai	Submittted/Under Review
Institutional Ethics Committee, North Eastern Indira Gandhi Regional Institute Health & Medical Sciences, Shilong	Submittted/Under Review
KEM Hospital Research Ethics Committee	Submittted/Under Review

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: I219\|\|Acute myocardial infarction, unspecified,

Intervention / Comparator Agent

Type	Name	Details
Comparator Agent	Ischemia Driven Strategy	Patients recruited in the conservative group will be admitted and monitored in the hospital. If they develop recurrent ischemia, hemodynamic instability, or decompensated heart failure will be taken up for a PCI. They would undergo a symptom-limited exercise test before discharge. If there is stress-induced ischemia, they will be taken up for coronary angiography followed by PTCA or CABG for complete revascularization. This will be a one-time intervention and the procedure will take 30 - 60 minutes in case of PTCA and 2-3 hours in case of CABG. After that the patients will be followed up for an average of 2 years for outcome.
Intervention	Routine Invasive Strategy for percutaneous Intervention	Patients randomized to the routine invasive therapy arm will be taken up for coronary angiography followed by stenting (within 24 hours of hospitalization) or CABG depending on coronary status. This will be a one-time intervention and the procedure will take 30 - 60 minutes in case of PCI and 2-3 hours in case of CABG. After that the patients will be followed up for an average of 2 years for outcome.

Inclusion Criteria

Age From	18.00 Year(s)
Age To	80.00 Year(s)
Gender	Both
Details	Age greater than or equals to 18 years, less than or equals to 80 years Patients having ST-segment elevation myocardial infarction (STEMI) which is defined as at least one episode of angina or angina equivalent lasting for greater than or equals to 30 minutes and supportive ECG changes as follows â€“ - ST-segment elevation (measured at the J-point): in at least two contiguous leads with ST-segment elevation greater than or equals to 2.5 mm in men less than 40 years, greater than or equals to 2 mm in men less than 40years, or greater than or equals to 1.5mm in women in leads V2â€“V3 and/or greater than or equals to 1mm in the other leads [in the absence of left ventricular (LV) hypertrophy or left bundle branch block LBBB)]. In the presence of LBBB, presence of concordant ST elevation greater than or equals to 1 mm in greater than or equals to 1 lead/ concordant ST depression greater than or equals to 1 mm in greater than or equals to 1 lead of V1-V3/ proportionally excessive discordant STE in greater than or equals to 1 lead anywhere with less than or equals to 1 mm STE, as defined by greater than or equals to 25% of the depth of the preceding S-wave (Smith-modified Sgarbossa Criteria) New Q-waves of greater than or equals to 0.03 sec and or 1by3 of QRS complex in greater than or equals to 2 related EKG leads. Patient presenting greater than 12 hours, but less than 72 hours of symptom onset. Not revascularized by either thrombolysis or PCI.

ExclusionCriteria

Details

i. Clinical indications of revascularization: symptom suggestive of ongoing ischemia, hemodynamic instability (Systolic blood pressure less than 90 mmHg, unresponsive to fluids, or requiring ionotropic support), refractory angina, severe congestive heart failure and/or pulmonary edema, complete heart block, refractory arrhythmia.
ii. Patients presenting with mechanical complications of STEMI â€“ ventricular septal rupture, ventricular free wall rupture, acute severe mitral regurgitation due to papillary muscle rupture.
iii. Other serious illnesses with poor life expectancy like â€“ malignancy, severe pulmonary disease, severe liver disease
iv. Severe renal dysfunction with serum creatinine greater than or equals to 2 mg/dl that may increase the risk of contrast nephropathy.
v. Patient who had prior CABG and qualifying infarct-related artery has been grafted previously.
vi. Severe valvular heart disease
vii. History of allergy or anaphylaxis with contrast agents.
viii. Pregnancy
ix. Contraindication to antiplatelet therapy
x. Active bleeding or bleeding diatheses
xi. Recent trauma or major surgery (during the last month); Relevant hematologic deviations (hemoglobin less than 10 g/dL or hematocrit 34%, platelet cell count of less than 100 x 103/Î¼L, white blood cell count less than 3 x 103/Î¼L).
xii. Recent PCI (within the last 30 days)
xiii. Previous stroke (within the last 3 months)
xiv. Known case of hypertrophic or restrictive cardiomyopathy
xv. Inability to cooperate with protocol and long term follow up
Refusal or inability to give informed consent.

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

Centralized

Blinding/Masking

Outcome Assessor Blinded

Primary Outcome

Outcome	TimePoints
Composite endpoint of all-cause mortality, recurrent non-fatal MI, congestive heart failure hospitalization	Outcome will be assessed at Baseline, 4th Month, 8th Month, 12th Month, 16th Month, 20th Month and 24th Month.

Secondary Outcome

Outcome	TimePoints
all-cause mortality, recurrent non-fatal MI, congestive heart failure hospitalization, Health-related quality of life, Change in left ventricular ejection fraction, A composite of the first to occur of death, recurrent MI, heart failure hospitalization, sustained ventricular arrhythmia, automatic implantable cardiac defibrillator (AICD) placement, or stroke.	Outcome will be assessed at Baseline, 4th Month, 8th Month, 12th Month, 16th Month, 20th Month & 24th Month.

Target Sample Size

Total Sample Size="1890"
Sample Size from India="1890"
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 4

Date of First Enrollment (India)

01/08/2024

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="4"
Months="0"
Days="0"

Recruitment Status of Trial (Global)
Modification(s)

Not Applicable

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

a) Gaps in existing knowledge: The benefit of early invasive strategy in STEMI patients presenting late after conventional myocardial salvage period of 12 hours but before 48 hours of symptom onset is controversial and unexplored.

b) Novelty: The proposed trial will be the first study to assess the effect of early invasive strategy based on PCI with stenting in STEMI patients presenting late i.e., 12-48 hours of symptom onset and without any symptom suggestive of ongoing ischemia, hemodynamic instability, refractory angina. The study has been designed to include a large sample size to obtain a definite conclusion with adequate power.

c) Objective: The primary objective will be to assess the role of early invasive strategy in reducing a composite endpoint of all-cause mortality, recurrent non-fatal MI, congestive heart failure hospitalization compared with a conservative ischemia driven strategy.

d) Methods: The study will be a multicentre, prospective, parallel-group, open-level randomized control trial. All STEMI patients presenting late to emergency department of the participating centres within 12- 48 hours of symptom onset without any revascularization by thrombolysis or primary PCI after satisfying eligibility criteria will be randomized in a 1:1 ratio to the â€˜early invasive therapyâ€™ or â€˜conservative ischemia driven strategyâ€™ arms. All patients will be assessed for average two years for the composite outcome.

e) Expected outcome: We expect that early invasive strategy will result in significant benefits in terms of all-cause mortality, recurrent non-fatal MI, congestive heart failure hospitalization in STEMI patients presenting 12-48 hours after pain onset.