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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: CTRI
Last refreshed on: 24 November 2021
Main ID:  CTRI/2017/09/009792
Date of registration: 15-09-2017
Prospective Registration: Yes
Primary sponsor: European Cardiovascular Research Institute ECRI
Public title: Short or longer duration of blood thinners after stent implantation to treat narrowing(s) of heart vessels in subjects in whom the risk of suffering from bleeding complications is higher than average.
Scientific title: MAnagement of high bleeding risk patients post bioresorbable polymer coated STEnt implantation with an abbReviated versus prolonged DAPT regimen â?? MASTER DAPT - MASTER DAPT
Date of first enrolment: 15-09-2017
Target sample size: 4300
Recruitment status: Closed to Recruitment of Participants
URL:  http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=19979
Study type:  Interventional
Study design:  Randomized, Parallel Group Trial
Method of generating randomization sequence:Stratified block randomization Method of allocation concealment:Centralized Blinding and masking:Outcome Assessor Blinded
 
Phase:  Phase 4
Countries of recruitment
Argentina Australia Austria Bahrain Bangladesh Belgium Bulgaria Colombia
Czech Republic Denmark Estonia France Germany Hungary India Israel
Italy Japan Netherlands Poland Portugal Republic of Korea Saudi Arabia Serbia
Singapore Slovenia Spain Sweden Switzerland United Kingdom Viet Nam
Contacts
Name: Sankardas Mullasari Ajit   
Address:  Clinical Research Department- T Block 4-A, Dr. J.J. Nagar, Mogappair Chennai - 600037 India 600037 Chennai, TAMIL NADU India
Telephone: 04426565974
Email: clireco@mmm.org.in
Affiliation:  Madras Medical Mission
Name: Sankardas Mullasari Ajit   
Address:  Clinical Research Department- T Block 4-A, Dr. J.J. Nagar, Mogappair Chennai - 600037 India 600037 Chennai, TAMIL NADU India
Telephone: 04426565974
Email: clireco@mmm.org.in
Affiliation:  Madras Medical Mission
Key inclusion & exclusion criteria
Inclusion criteria: Inclusion criteria after index PCI

After index PCI, patients aged 18 years or more are eligible for inclusion into the

study if the following criteria are met.

1. At least one among the HBR criteria (as defined below) is met.

2. All lesions are successfully treated with Ultimaster stent in the context of

3. routine clinical care, i.e. post-procedural angiographic diameter stenosis <20% by visual estimation

4. Free from any flow-limiting angiographic complications (i.e. significant untreated dissection or major side-branch occlusion), which require prolonged

5. DAPT duration based on operatorâ??s opinion.

6. All stages of PCI are complete (if any) and no further PCI is planned.



Inclusion criteria at one-month randomization visit

At randomization visit (one month after index PCI), the following criteria must be met:

1. Fulfilment of at least one HBR criterion (as defined below), or on the basis of post-PCI actionable (i.e. requiring medical attention) non-access site related bleeding episode

2. Uneventful 30-day clinical course, i.e. free from spontaneous MI, symptomatic restenosis, stent thrombosis, stroke and any revascularization (coronary and non-coronary) requiring prolonged DAPT



3. If not on OAC,



a. Patient is on a DAPT regimen of aspirin and a P2Y12 inhibitor

b. Patient with one type of P2Y12 inhibitor for at least 7 days (i.e. no switching between oral P2Y12 inhibitors has occurred in the previous 7 days)



4. If on OAC



a. Patient is on the same type of OAC (e.g. Vitamin K antagonist or NOAC) for at least 7 days

b. Patient is on clopidogrel for at least 7 days



Definition of HBR

Post-PCI patients are at HBR if at least one of the following criteria applies:

1. Clinical indication for treatment with oral anticoagulants (OAC) for at least 12 months

2. Recent ( <12 months) non-access site bleeding episode(s), which required medical attention (i.e. actionable bleeding).

3. Previous bleeding episode(s) which required hospitalization if the underlying cause has not been definitively treated (i.e. surgical removal of the bleeding source)

4. Age equal or greater than 75 years

5. Systemic conditions associated with an increased bleeding risk (e.g. haematological disorders, including a history of or current thrombocytopaenia defined as a platelet count <100,000/mm3 ( <100 x 109/L), or any known coagulation disorder associated with

increased bleeding risk.

6. Documented anaemia defined as repeated haemoglobin levels <11 g/dl or transfusion within 4 weeks before inclusion.

7. Need for chronic treatment with steroids or non-steroidal anti-inflammatory drugs

8. Diagnosed malignancy (other than skin) considered at high bleeding risk including gastro-intestinal, genito-urethral/renal and pulmonary.

9. Stroke at any time or TIA in the previous 6 months

10. PRECISE DAPT score of 25 or greater


Exclusion criteria: Patients are not eligible if any of the following applies

1. Treated with stents other than Ultimaster stent within 6 months prior to index procedure

2. Treated for in-stent restenosis or stent thrombosis at index PCI or within 6 months before

3. Treated with a bioresorbable scaffold at any time prior to index procedure

4. Cannot provide written informed consent

5. Under judicial protection, tutorship or curatorship

6. Unable to understand and follow study-related instructions or unable to comply with study protocol

7. Active bleeding requiring medical attention (BARC>=2) on randomization visit

8. Life expectancy less than one year

9. Known hypersensitivity or allergy for aspirin, clopidogrel, ticagrelor, prasugrel, cobalt chromium or sirolimus

10. Any planned and anticipated PCI

11. Participation in another trial

12. Pregnant or breast feeding women



Age minimum:
Age maximum:
Gender:
Health Condition(s) or Problem(s) studied
Health Condition 1: I259- Chronic ischemic heart disease, unspecified Health Condition 2: null- High Bleeding Risk Patients with myocardial ischemia
Intervention(s)
Intervention1: abbreviated dual antiplatelet therapy (DAPT): Patients not on oral anticoagulant (OAC): DAPT is discontinued and a single anti-platelet agent (SAPT) is continued until at least 11 months post randomization.
Patients on oral anticoagulant (OAC): DAPT is discontinued and either aspirin or clopidogrel is continued until 5 months post randomization. OAC is continued until at least 11 months post randomization.
Study regimens are implemented by regular drug prescription as described above.The followings are recommended according to the current guidelines and local practice.
- Aspirin is prescribed in standard dose of at least 75 mg/day and up to 162 mg/day.
- Clopidogrel is prescribed in standard dose of 75 mg once daily.
- Prasugrel is prescribed in standard dose of 10mg/day or 5mg/ day in patients weighing less than 60 kg or who are over 75 years old. In regions where other standard dose exists
(i.e. Japan), prasugrel dosage is adjusted according to the locally approved dose.
- Ticagrelor is prescribed in standard dose of 180 mg/day (90mg bid).
- Vitamin K antagonist is dosed to keep INR within guidelines.
- NOACs (rivaroxaban, edoxaban, dabigatran and apixaban) are given in locally approved doses.
Control Intervention1: prolonged dual antiplatelet therapy (DAPT): Patients not on oral anticoagulant (OAC): DAPT is discontinued and a single anti-platelet agent (SAPT) is continued until at
least 11 months post randomization.
Patients on oral anticoagulant (OAC):DAPT is discontinued and either aspirin or clopidogrel is continued until 5 months
post randomization. OAC is continued until at least 11 months post randomization.
Study regimens are implemented by regular drug prescription as described above.The followings are recommended according to the current guide
Primary Outcome(s)
This study has 3 primary endpoints:

1) Net adverse clinical endpoints (NACE) defined as a composite of all-cause death,myocardial infarction,stroke,bleeding events (BARC 3 and 5)

2) Major adverse cardiac and cerebral events (MACCE) defined as a composite of all-cause death, myocardial infarction, stroke

3) Major or clinically relevant non-major bleeding (MCB) defined as a composite of bleeding events according to BARC type 2, 3 and 5Timepoint: from randomization up to 11 months after
Secondary Outcome(s)
7) Any target vessel revascularization

8) Urgent target vessel revascularization

9) Urgent non-target vessel revascularization

10) Clinically indicated non-target vessel revascularization

11) Bleeding events according to the BARC, TIMI and GUSTO classification

12) Transfusion rates both in patients with and/or without clinically detected overt

bleedingTimepoint: from randomization up to 14 months after
1) The individual components of each composite primary endpoints

2) The composite of cardiovascular death, MI, and stroke

3) The composite of cardiovascular death, MI, and any revascularization

4) Death from cardiovascular causes

5) The composite of definite or probable stent thrombosis

6) Myocardial infarction

Timepoint: from randomization up to 14 months after
Secondary ID(s)
Version 1.0 dated November 2, 2016
Source(s) of Monetary Support
Terumo Europe NV Interleuvenlaan 40 3001 Leuven Belgium
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date: 01/07/2017
Contact:
G Kuppuswamy Naidu Memorial Hospital
Status: Approved
Approval date: 05/08/2017
Contact:
Institutional Ethics Committee Madras Medical Mission
Status: Approved
Approval date: 17/08/2017
Contact:
Indipendent Ethics Committee Shree B D Mehta Mahavir Heart Institute
Status: Approved
Approval date: 24/10/2017
Contact:
Institutional Ethics Committee Clinical Studies Apollo Hospital
Status: Not Applicable
Approval date:
Contact:
Indipendent Ethics Committee Sir Gangaram Hospital
Results
Results available:
Date Posted:
Date Completed:
URL:
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