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

Not Applicable

Active, not recruiting

• Conditions: Angioplasty, Balloon; Antiplatelet Drug; Acute Coronary Syndrome
• Interventions: Drug: Aspirin 100mg for 1-month (immediately after PCI); Drug: Aspirin 100mg for 12-month (immediately after PCI); Drug: Ticagrelor 90mg for 6-month (immediately after PCI); Drug: Ticagrelor 90mg for 12-month (immediately after PCI); Drug: Aspirin 100mg for 6-month (6-month post PCI)

• Registration Number: NCT04971356
• Lead Sponsor: Xijing Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-07-20
• Study First Submitted QC: 2021-07-20
• Study First Posted: 2021-07-21
• Study Start: 2021-11-01
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-12
• Last Update Posted: 2023-11-14
• Primary Completion: 2024-03-01
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1948

Inclusion Criteria

1. Patients with an indication for PCI due to acute coronary syndrome
2. All target lesions can be successful treatment of PCI with drug-coated balloon (DCB)
3. Patients who are able to complete the follow-up and compliant to the prescribed medication

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Exclusion Criteria

1. Under the age of 18 or Older than 80 years old
2. Unable to give informed consent
3. 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)
4. Known contraindication to medications such as Heparin, antiplatelet drugs, or contrast.
5. Currently participating in another trial and not yet at its primary endpoint
6. Planned elective surgery
7. Concurrent medical condition with a life expectancy of less than 1 years
8. Previous intracranial haemorrhage
9. Need long-term oral anticoagulant therapy
10. Cardiogenic shock
11. Previous stent implantation 6 month
12. In-stent thrombosis
13. Target lesion located in surgical conduit

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental arm	Ticagrelor 90mg for 6-month (immediately after PCI)	1-month of Aspirin + Ticagrelor, followed by 5-month of Ticagrelor monotherapy; Afterward, Aspirin monotherapy for 6 months
Experimental arm	Aspirin 100mg for 6-month (6-month post PCI)	1-month of Aspirin + Ticagrelor, followed by 5-month of Ticagrelor monotherapy; Afterward, Aspirin monotherapy for 6 months
Experimental arm	Aspirin 100mg for 1-month (immediately after PCI)	1-month of Aspirin + Ticagrelor, followed by 5-month of Ticagrelor monotherapy; Afterward, Aspirin monotherapy for 6 months
Reference arm	Aspirin 100mg for 12-month (immediately after PCI)	12-month Aspirin plus Ticagrelor
Reference arm	Ticagrelor 90mg for 12-month (immediately after PCI)	12-month Aspirin plus Ticagrelor

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Ling Tao; 🇨🇳 Xi'an, Shannxi, China