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CTRI Number  CTRI/2023/10/059339 [Registered on: 31/10/2023] Trial Registered Prospectively
Last Modified On: 30/10/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   An observation study to evaluate safety and efficacy of antiplatelet drugs in patients after percutaneous coronary intervention. 
Scientific Title of Study   To evaluate the safety and efficacy of antiplatelet strategies in patients undergoing percutaneous coronary intervention with drug-eluting stents: A Prospective Observational Study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Pragya Hangma Subba 
Designation  Junior Resident 
Affiliation  Jawaharlal Nehru Medical College Aligarh Muslim University Aligarh 
Address  Department of Pharmacology Jawaharlal Nehru medical college Aligarh Muslim University Aligarh

Aligarh
UTTAR PRADESH
202001
India 
Phone  7080560474  
Fax    
Email  pragyahsubba@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Jameel Ahmad 
Designation  Assistant Professor 
Affiliation  Jawaharlal Nehru Medical College Aligarh Muslim University Aligarh 
Address  Department of Pharmacology Jawaharlal Nehru medical college Aligarh Muslim University Aligarh

Aligarh
UTTAR PRADESH
202001
India 
Phone  7599529550  
Fax    
Email  ahmad.drjameel@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Pragya Hangma Subba 
Designation  Junior Resident 
Affiliation  Jawaharlal Nehru Medical College Aligarh Muslim University Aligarh 
Address  Department of Pharmacology Jawaharlal Nehru medical college Aligarh Muslim University Aligarh

Aligarh
UTTAR PRADESH
202001
India 
Phone  7080560474  
Fax    
Email  pragyahsubba@gmail.com  
 
Source of Monetary or Material Support  
Jawaharlal Nehru Medical College and Hospital Department of Cardiology Aligarh Muslim University Aligarh, Uttar Pradesh 
 
Primary Sponsor  
Name  Pragya Hangma Subba 
Address  Junior Resident Department of Pharmacology Jawaharlal Nehru Medical College Aligarh Muslim University Aligarh, Uttar Pradesh 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Pragya Hangma Subba  Jawaharlal Nehru Medical Hospital,AMU  Department of Cardiology , Room no 15 Jawaharlal Nehru Medical Hospital, Aligarh Muslim University.
Aligarh
UTTAR PRADESH 
7080560474

pragyahsubba@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Jawaharlal Nehru Medical college & Hospital, Faculty of Medicine Aligarh Muslim University, Aligarh U.P. India - 202002   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I22||Subsequent ST elevation (STEMI) and non-ST elevation (NSTEMI) myocardial infarction,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Patients above 18 years of age have documented administration of at least two different oral DAPT after PCI with DES implantation. 
 
ExclusionCriteria 
Details  1. Patients with active bleeding or bleeding disorder
2. Patients with contraindications to antiplatelet therapy
3. Patients with ongoing long-term treatment with oral anticoagulants 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The primary endpoint is Net Adverse Clinical Events ( NACE ) within 3-6 months of percutaneous coronary intervention, which includes major adverse cardiac and cerebrovascular events (MACCE) plus major bleeding includes the composite of all-cause death, myocardial infarction, stent thrombosis, stroke, and target vessel revascularization.  3-6 months after percutaneous coronary intervention. 
 
Secondary Outcome  
Outcome  TimePoints 
Secondary endpoints included each component of the primary endpoint.
The incidence of the primary outcome of MACE observed when switching to an alternative oral P2Y12 inhibitor. 
3-6 months 
 
Target Sample Size   Total Sample Size="146"
Sample Size from India="146" 
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)   10/11/2023 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

According to the World Health Organization (WHO), CVD is the leading cause of death worldwide, accounting for an estimated 17.9 million deaths each year. This represents about 31% of all deaths worldwide.Although substantial progress has been made in the diagnosis and treatment of acute coronary syndromes (ACS), cardiovascular disease remains the leading cause of death worldwide, with nearly half of these deaths due to ischaemic heart disease.Effective secondary prevention after ACS involves prompt recognition of symptoms, early hospitalization, and initiation of appropriate medical therapy. Revascularization, antiplatelet therapy, lipid-lowering therapy, and blood pressure control are all important components of ACS management. Antiplatelet therapy represents the cornerstone treatment and secondary prevention of CAD. Compared with placebo, antiplatelet therapy has been shown to reduce recurrent major adverse cardiovascular events (MACE) among patients with stable CAD or ACS, however, it is inevitably associated with increased bleeding.Patients with ACS undergoing percutaneous coronary intervention (PCI) with drug-eluting stents (DES) are currently recommended dual antiplatelet therapy (DAPT), consisting of aspirin with P2Y12 receptor inhibitors to prevent thrombotic complications such as stent thrombosis. Patients receive DAPT for 6-12 months after DES implantation. The efficacy and safety of prolonged DAPT have been questioned. Compared to less than 12 months of DAPT, 12 months of DAPT did not reduce the risk of myocardial infarction, stent thrombosis, strokes, or cardiac or all-cause mortality, but increased the risk of major bleeds.DAPT beyond 12 months reduces the risk of myocardial infarction and stent thrombosis, but there is a substantial increase in major bleeding risk and all-cause mortality which need to be addressed. DAPT with aspirin and a P2Y12 inhibitor is recommended following an acute coronary syndrome (ACS) to help prevent further thromboembolic events.There are three commercially available oral P2Y12 inhibitors; clopidogrel, prasugrel, and ticagrelor. Clopidogrel is the most commonly used agent, likely due to its cost-effectiveness compared to the other two agents. However, clinical trials have shown that both prasugrel and ticagrelor are associated with lower rates of CV death, MI, or stroke when compared to clopidogrel in the management of ACS .Safety concerns exist surrounding the appropriate strategy for switching between oral P2Y12 inhibitors. Due to the pharmacological and pharmacokinetic differences between oral P2Y12 inhibitors, including half-life, site of action, mechanism, and onset of action, there may be concern that switching between agents could lead to a period of inadequate platelet inhibition and further thromboembolic events. In contrast, there may be concern that a period of more robust platelet inhibition could occur while switching between agents, raising the risk of potential bleeding.Guidance on the best modality for switching between these agents had been lacking, particularly regarding timing and the need for reloading. This study aims to evaluate the safety and efficacy of different antithrombotic strategies, particularly for switching between oral P2Y12 inhibitors at our institution, and compare our findings to the most recently published expert consensus recommendations.

 
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