1-month DAPT Plus 5-month Ticagrelor Monotherapy Versus 12-month DAPT in Patients With Drug-coated Balloon

Study Overview
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Brief Summary
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Drug-Coated Balloon (DCB) angioplasty is similar to plain old balloon angioplasty procedurally, but there is an anti-proliferative medication paclitaxel coated to the balloon. Treating ISR lesions with the DCB has the theoretical advantage of avoiding multiple stent layers and respecting the vessel anatomy. DCB has shown promising results for the treatment of ISR. Currently, DCB has a Class I indication to treat ISR recommended by European Society of Cardiology guidelines. In addition, some interventional cardiologist has also applied DCB in de novo lesions in their clinical practice. Bleeding after PCI remains a substantial clinical problem. Bleeding post-PCI increases the risk of adverse outcomes such as death, non-fatal myocardial infarction, and prolongs hospital stay. Clinical data has suggested that major bleeding post-PCI would increase the risk of mortality 5.7-fold. The antiplatelet medications are the major cause of bleeding events post-PCI. Current guidelines for stents recommended DAPT of aspirin plus a P2Y12 inhibitor for at least 12 months after stent implantation in patients with the acute coronary syndrome. Compared with the DES, because of the absence of metal inside the coronary artery, the use of DCB might theoretically allow shorter duration antiplatelet therapy. However, the optimal course of DAPT for the DCB treated patients remains controversial. In 2013, the consensus from the German group suggested that for the acute coronary syndrome, DAPT should be used for 12 months. The consensus of DAPT developed by the European Society of Cardiology (ESC) in 2017 stated that in patients treated with DCB, dedicated clinical trials investigating the optimal duration of DAPT are lacking. So far, there are no randomized data showing the optimal DAPT duration for the DCB treated patients. In the current study, we use Aspirin + Ticagrelor for 1-month followed by Ticagrelor monotherapy for 5-month, afterward, Aspirin monotherapy for 6 months to be the antiplatelet regimen in the experimental arm, to compare with the Reference arm, which is Aspirin + Ticagrelor for 12-month in a non-inferiority statistical assumption, aiming to investigate the optimal duration of the DAPT in ACS patients after DCB treatment.

Official Title
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Aspirin Plus Ticagrelor for 1 Month Followed by 5 Months Ticagrelor Monotherapy Versus Aspirin Plus Ticagrelor for 12 Months in Acute Coronary Syndrome Patients With Drug-coated Balloon: a Multicentre, Randomized, Non-inferiority Trial

Conditions
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Antiplatelet Drug, Acute Coronary Syndrome, Angioplasty, Balloon

Intervention / Treatment
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* Drug: Aspirin 100mg for 1-month (immediately after PCI)
* Drug: Ticagrelor 90mg for 6-month (immediately after PCI)
* Drug: Aspirin 100mg for 6-month (6-month post PCI)
* Drug: Aspirin 100mg for 12-month (immediately after PCI)
* Drug: Ticagrelor 90mg for 12-month (immediately after PCI)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with an indication for PCI due to acute coronary syndrome All target lesions can be successful treatment of PCI with drug-coated balloon (DCB) Patients who are able to complete the follow-up and compliant to the prescribed medication Exclusion Criteria: Under the age of 18 or Older than 80 years old Unable to give informed consent Patient is a woman who is pregnant or nursing (a pregnancy test must be performed within 7 days prior to the index procedure in women of child-bearing potential according to local practice) Known contraindication to medications such as Heparin, antiplatelet drugs, or contrast. Currently participating in another trial and not yet at its primary endpoint Planned elective surgery Concurrent medical condition with a life expectancy of less than 1 years Previous intracranial haemorrhage Need long-term oral anticoagulant therapy Cardiogenic shock Previous stent implantation 6 month In-stent thrombosis Target lesion located in surgical conduit

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental arm<br>1-month of Aspirin + Ticagrelor, followed by 5-month of Ticagrelor monotherapy; Afterward, Aspirin monotherapy for 6 months | Drug: Aspirin 100mg for 1-month (immediately after PCI)<br>* Aspirin for 1-month immediately after PCI to be a part of medication treatment in the Experimental arm<br>Drug: Ticagrelor 90mg for 6-month (immediately after PCI)<br>* Ticagrelor for 6-month immediately after PCI to be a part of medication treatment in the Experimental arm<br>Drug: Aspirin 100mg for 6-month (6-month post PCI)<br>* Aspirin for 6-month at 6 months post-PCI (after the discontinuation of the 6-month Ticagrelor treatment) to be a part of medication treatment in the Experimental arm<br>|
| Active Comparator: Reference arm<br>12-month Aspirin plus Ticagrelor | Drug: Aspirin 100mg for 12-month (immediately after PCI)<br>* Aspirin for 12-month immediately after PCI to be a part of medication treatment in the Reference arm<br>Drug: Ticagrelor 90mg for 12-month (immediately after PCI)<br>* Ticagrelor for 12-month immediately after PCI to be a part of medication treatment in the Reference arm<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Net adverse clinical events (NACE) | NACE is a composite clinical endpoint of all-cause death, any stroke, any MI, any revascularization and BARC type 3 or 5 bleeding events | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Any ischemic or bleeding event | Any ischemic and bleeding event includes any all-cause death, any stroke, MI, BARC-defined type 3 bleeding, any revascularization and BARC-defined type 2 bleeding events | 1, 6 and 12 months | 
| BARC type 3 or 5 bleeding events | Bleeding events type 3 or 5 defined by BARC (Bleeding Academic Research Consortium) criteria | 1, 6 and 12 months | 
| BARC type 2 ,3 or 5 bleeding events | Bleeding events type 2, 3 or 5 defined by BARC (Bleeding Academic Research Consortium) criteria | 1, 6 and 12 months | 
| BARC defined type 2 bleeding events | Bleeding events type 2 defined by BARC (Bleeding Academic Research Consortium) criteria | 1, 6 and 12 months | 
| Rate of NACE | NACE is a composite clinical endpoint of all-cause death, any stroke, any MI, any revascularization and BARC type 3 or 5 bleeding events | 1 and 6 months | 
| Device-oriented Composite Endpoint (DoCE) | DoCE is a composite clinical endpoint of cardiac cause death, target vessel myocardial infraction (TV-MI), and Clinically individual target lesion revascularization (CI-TLR) | 1, 6 and 12 months | 
| Cardiac death | Rates of individual components of DoCE | 1, 6 and 12 months | 
| Target vessel myocardial infraction (TV-MI) | Rates of individual components of DoCE | 1, 6 and 12 months | 
| Clinically individual target lesion revascularization (CI-TLR) | Rates of individual components of DoCE | 1, 6 and 12 months | 
| Patient-oriented Composite Endpoint (PoCE) | The primary safety endpoint of PoCE is defined as all-cause death, any stroke, any MI, any revascularization | 1, 6 and 12 months | 
| All-cause death | Rates of individual components of PoCE | 1, 6 and 12 months | 
| Any MI | Rates of individual components of PoCE | 1, 6 and 12 months | 
| Any stroke | Rates of individual components of PoCE | 1, 6 and 12 months | 
| Any revascularization | Rates of individual components of PoCE | 1, 6 and 12 months | 
| Target vessel failure (TVF) | Target vessel failure is defined as cardiovascular death, target vessel myocardial infraction (TV-MI), and clinically-indicated target vessel revascularization | 1, 6 and 12 months | 
| Clinically-indicated target vessel revascularization | Rates of individual components of TVF | 1, 6 and 12 months | 
| Definite/Probable stent thrombosis rates |  | 1, 6 and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ticagrelor Monotherapy, Acute coronary syndrome, Drug-coated balloons