| 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
|
|
|
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 |
|
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Regulatory Clearance Status from DCGI
|
|
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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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