Antiplatelet DrugCAGEFREEIINCT04971356
1-month DAPT Plus 5-month Ticagrelor Monotherapy Versus 12-month DAPT in Patients With Drug-coated Balloon
A study testing Aspirin 100mg for 1-month (immediately after PCI), Ticagrelor 90mg for 6-month (immediately after PCI) and Aspirin 100mg for 6-month (6-month post PCI) in people with Antiplatelet Drug and Acute Coronary Syndrome, run by Xijing Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Antiplatelet Drug, Acute Coronary Syndrome, Angioplasty, Balloon
- What is being tested?
- Aspirin 100mg for 1-month (immediately after PCI), Ticagrelor 90mg for 6-month (immediately after PCI) and Aspirin 100mg for 6-month (6-month post PCI)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,948 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2021to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read more
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.
- Being tested
- Aspirin 100mg for 1-month (immediately after PCI), Ticagrelor 90mg for 6-month (immediately after PCI), Aspirin 100mg for 6-month (6-month post PCI), Aspirin 100mg for 12-month (immediately after PCI), Ticagrelor 90mg for 12-month (immediately after PCI)
- Keywords
- Ticagrelor Monotherapy, Acute coronary syndrome, Drug-coated balloons
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aspirin 100mg for 1-month (immediately after PCI)Drug
Aspirin for 1-month immediately after PCI to be a part of medication treatment in the Experimental arm
Ticagrelor 90mg for 6-month (immediately after PCI)Drug
Ticagrelor for 6-month immediately after PCI to be a part of medication treatment in the Experimental arm
Aspirin 100mg for 6-month (6-month post PCI)Drug
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
Aspirin 100mg for 12-month (immediately after PCI)Drug
Aspirin for 12-month immediately after PCI to be a part of medication treatment in the Reference arm
Ticagrelor 90mg for 12-month (immediately after PCI)Drug
Ticagrelor for 12-month immediately after PCI to be a part of medication treatment in the Reference arm
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm | Experimental | 1-month of Aspirin + Ticagrelor, followed by 5-month of Ticagrelor monotherapy; Afterward, Aspirin monotherapy for 6 months Receives: 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) |
| Reference arm | Active comparator | 12-month Aspirin plus Ticagrelor Receives: Drug: Aspirin 100mg for 12-month (immediately after PCI); Drug: Ticagrelor 90mg for 12-month (immediately after PCI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (17)
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
Measured: 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
Measured: 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
Measured: 1, 6 and 12 months
BARC defined type 2 bleeding events
Bleeding events type 2 defined by BARC (Bleeding Academic Research Consortium) criteria
Measured: 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
Measured: 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)
Measured: 1, 6 and 12 months
Cardiac death
Rates of individual components of DoCE
Measured: 1, 6 and 12 months
Target vessel myocardial infraction (TV-MI)
Rates of individual components of DoCE
Measured: 1, 6 and 12 months
Clinically individual target lesion revascularization (CI-TLR)
Rates of individual components of DoCE
Measured: 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
Measured: 1, 6 and 12 months
All-cause death
Rates of individual components of PoCE
Measured: 1, 6 and 12 months
Any MI
Rates of individual components of PoCE
Measured: 1, 6 and 12 months
Any stroke
Rates of individual components of PoCE
Measured: 1, 6 and 12 months
Any revascularization
Rates of individual components of PoCE
Measured: 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
Measured: 1, 6 and 12 months
Clinically-indicated target vessel revascularization
Rates of individual components of TVF
Measured: 1, 6 and 12 months
Definite/Probable stent thrombosis rates
Measured: 1, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2021
- Study start1 Nov 2021
- Primary completion1 Mar 2024 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Antiplatelet DrugStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,948 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LingTao, Xijing Hospital
- Investigators
- Ling Tao, MD,PHD, Study chair, Xijing HospitalPatrick Serruys, MD,PHD, Study chair, National University of Ireland, Galway, IrelandYoshinobu Onuma, MD,PHD, Study chair, National University of Ireland, Galway, IrelandChao Gao, MD,PHD, Study chair, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04971356
- Sponsor's protocol ID
- CAGE-FREE II
- Acronym
- CAGEFREEII
- Status last verified
- Nov 2023
- First submitted
- 20 Jul 2021
- Last updated
- 14 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gao C, Zhu B, Ouyang F, Wen S, Xu Y, Jia W, Yang P, He Y, Zhong Y, Zhou Y, Guo Z, Shen G, Ma L, Xu L, Xue Y, Hu T, Wang Q, Liu Y, Zhang R, Liu J, Jiang Z, Xia J, Garg S, van Geuns RJ, Capodanno D, Onuma Y, Wang D, Serruys P, Tao L; REC-CAGEFREE II Investigators. Stepwise dual antiplatelet therapy de-escalation in patients after drug coated balloon angioplasty (REC-CAGEFREE II): multicentre, randomised, open label, assessor blind, non-inferiority trial. BMJ. 2025 Mar 31;388:e082945. doi: 10.1136/bmj-2024-082945.
PubMed 40164448Gao C, Zhu B, Liu J, Jiang Z, Hu T, Wang Q, Liu Y, Yuan M, Li F, Zhang R, Xia J, Onuma Y, Wang D, Serruys P, Tao L; REC-CAGEFREE II Study Group. Randomized evaluation of 5-month Ticagrelor monotherapy after 1-month dual-antiplatelet therapy in patients with acute coronary syndrome treated with drug-coated balloons: REC-CAGEFREE II trial rationale and design. BMC Cardiovasc Disord. 2024 Jan 20;24(1):62. doi: 10.1186/s12872-024-03709-1.
PubMed 38245724
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04971356
- Acronym / sponsor ID
- CAGEFREEII / CAGE-FREE II
- Keywords
- Ticagrelor Monotherapy, Acute coronary syndrome, Drug-coated balloons
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,948 participants (actual)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 1 Mar 2024 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 21 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental arm | Experimental | 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)1-month of Aspirin + Ticagrelor, followed by 5-month of Ticagrelor monotherapy; Afterward, Aspirin monotherapy for 6 months |
| Reference arm | Active comparator | Drug: Aspirin 100mg for 12-month (immediately after PCI), Drug: Ticagrelor 90mg for 12-month (immediately after PCI)12-month Aspirin plus Ticagrelor |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aspirin 100mg for 1-month (immediately after PCI)Aspirin for 1-month immediately after PCI to be a part of medication treatment in the Experimental arm | Drug | Experimental arm |
| Ticagrelor 90mg for 6-month (immediately after PCI)Ticagrelor for 6-month immediately after PCI to be a part of medication treatment in the Experimental arm | Drug | Experimental arm |
| Aspirin 100mg for 6-month (6-month post PCI)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 | Drug | Experimental arm |
| Aspirin 100mg for 12-month (immediately after PCI)Aspirin for 12-month immediately after PCI to be a part of medication treatment in the Reference arm | Drug | Reference arm |
| Ticagrelor 90mg for 12-month (immediately after PCI)Ticagrelor for 12-month immediately after PCI to be a part of medication treatment in the Reference arm | Drug | Reference arm |
Primary outcome
Net adverse clinical events (NACE)
Time frame: 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
17 secondary outcomes
Any ischemic or bleeding event
Time frame: 1, 6 and 12 months
BARC type 3 or 5 bleeding events
Time frame: 1, 6 and 12 months
BARC type 2 ,3 or 5 bleeding events
Time frame: 1, 6 and 12 months
BARC defined type 2 bleeding events
Time frame: 1, 6 and 12 months
Rate of NACE
Time frame: 1 and 6 months
Device-oriented Composite Endpoint (DoCE)
Time frame: 1, 6 and 12 months
Cardiac death
Time frame: 1, 6 and 12 months
Target vessel myocardial infraction (TV-MI)
Time frame: 1, 6 and 12 months
Clinically individual target lesion revascularization (CI-TLR)
Time frame: 1, 6 and 12 months
Patient-oriented Composite Endpoint (PoCE)
Time frame: 1, 6 and 12 months
All-cause death
Time frame: 1, 6 and 12 months
Any MI
Time frame: 1, 6 and 12 months
Any stroke
Time frame: 1, 6 and 12 months
Any revascularization
Time frame: 1, 6 and 12 months
Target vessel failure (TVF)
Time frame: 1, 6 and 12 months
Clinically-indicated target vessel revascularization
Time frame: 1, 6 and 12 months
Definite/Probable stent thrombosis rates
Time frame: 1, 6 and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2023.
- Derived from this study: PubMed 40164448Gao C, Zhu B, Ouyang F, Wen S, Xu Y, Jia W, Yang P, He Y, Zhong Y, Zhou Y, Guo Z, Shen G, Ma L, Xu L, Xue Y, Hu T, Wang Q, Liu Y, Zhang R, Liu J, Jiang Z, Xia J, Garg S, van Geuns RJ, Capodanno D, Onuma Y, Wang D, Serruys P, Tao L; REC-CAGEFREE II Investigators. Stepwise dual antiplatelet therapy de-escalation in patients after drug coated balloon angioplasty (REC-CAGEFREE II): multicentre, randomised, open label, assessor blind, non-inferiority trial. BMJ. 2025 Mar 31;388:e082945. doi: 10.1136/bmj-2024-082945.
- Derived from this study: PubMed 38245724Gao C, Zhu B, Liu J, Jiang Z, Hu T, Wang Q, Liu Y, Yuan M, Li F, Zhang R, Xia J, Onuma Y, Wang D, Serruys P, Tao L; REC-CAGEFREE II Study Group. Randomized evaluation of 5-month Ticagrelor monotherapy after 1-month dual-antiplatelet therapy in patients with acute coronary syndrome treated with drug-coated balloons: REC-CAGEFREE II trial rationale and design. BMC Cardiovasc Disord. 2024 Jan 20;24(1):62. doi: 10.1186/s12872-024-03709-1.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ling Tao, MD,PHD study chair
Xijing Hospital
Patrick Serruys, MD,PHD study chair
National University of Ireland, Galway, Ireland
Yoshinobu Onuma, MD,PHD study chair
National University of Ireland, Galway, Ireland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aspirin 100mg for 1-month (immediately after PCI), Ticagrelor 90mg for 6-month (immediately after PCI) and Aspirin 100mg for 6-month (6-month post PCI) in people with Antiplatelet Drug and Acute Coronary Syndrome, run by Xijing Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Net adverse clinical events (NACE) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04971356, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2023.