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.
- Conditions
- Health Condition 1: I259- Chronic ischemic heart disease, unspecifiedHealth Condition 2: null- High Bleeding Risk Patients with myocardial ischemia
- Registration Number
- CTRI/2017/09/009792
- Lead Sponsor
- European Cardiovascular Research Institute ECRI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 147
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method This study has 3 primary endpoints: <br/ ><br>1) Net adverse clinical endpoints (NACE) defined as a composite of all-cause death,myocardial infarction,stroke,bleeding events (BARC 3 and 5) <br/ ><br>2) Major adverse cardiac and cerebral events (MACCE) defined as a composite of all-cause death, myocardial infarction, stroke <br/ ><br>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 Measures
Name Time Method 1) The individual components of each composite primary endpoints <br/ ><br>2) The composite of cardiovascular death, MI, and stroke <br/ ><br>3) The composite of cardiovascular death, MI, and any revascularization <br/ ><br>4) Death from cardiovascular causes <br/ ><br>5) The composite of definite or probable stent thrombosis <br/ ><br>6) Myocardial infarction <br/ ><br>Timepoint: from randomization up to 14 months after;7) Any target vessel revascularization <br/ ><br>8) Urgent target vessel revascularization <br/ ><br>9) Urgent non-target vessel revascularization <br/ ><br>10) Clinically indicated non-target vessel revascularization <br/ ><br>11) Bleeding events according to the BARC, TIMI and GUSTO classification <br/ ><br>12) Transfusion rates both in patients with and/or without clinically detected overt <br/ ><br>bleedingTimepoint: from randomization up to 14 months after