Coronary Arterial Disease (CAD)SHORTDAPTNCT06648720
Efficacy and Safety of Shortening Dual Antiplatelet Therapy Duration with IVUS Guidance in PCI Patients
A study testing DAPT de-escalation in people with Coronary Arterial Disease (CAD) and Percutaneous Coronary Intervention (PCI), run by University Medical Center Ho Chi Minh City (UMC) at 1 site in Vietnam.
Trial summary
This study is designed to assess the efficacy and safety of de-escalating dual antiplatelet therapy (DAPT) at 1 month compared to the standard 12 months of therapy in patients undergoing percutaneous coronary intervention (PCI) guided by intravascular ultrasound (IVUS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Arterial Disease (CAD), Percutaneous Coronary Intervention (PCI), Intravascular Ultrasound
- What is being tested?
- DAPT de-escalation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,566 participants
- Where
- 1 siteVietnam
- Study dates
- 1 Mar 2025to 1 Mar 2029
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 years or older.
- Patients undergoing percutaneous coronary intervention (PCI) with drug-eluting stents (DES).
- Patients with the following clinical indications for PCI:
- Unstable Angina: Prolonged chest pain at rest, new-onset angina within the past 2 months, or increasing frequency/severity of angina attacks.
- Acute Myocardial Infarction (MI): With or without ST-elevation.
- Chronic Coronary Syndrome: Requiring coronary revascularization.
- Patients who agree to participate and provide informed consent.
Who cannot join
- Inability to Provide Informed Consent: Patients who are unable or unwilling to provide consent.
- Neurological Complications: Stroke or any permanent neurological deficits within the last 3 months.
- Coronary Artery Bypass Graft Surgery: History of CABG surgery.
- Planned Surgery: Patients who have surgeries planned within the next 12 months.
- Severe Chronic Kidney Disease: Patients with an estimated glomerular filtration rate (eGFR) of less than 20 ml/min/1.73 m² or patients on dialysis.
- Chronic Anticoagulation Therapy: Patients requiring chronic oral anticoagulation (e.g., warfarin, DOACs) beyond DAPT.
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- Thrombocytopenia: Platelet count less than 100,000/mm³.
- Contraindications to Antiplatelet Therapy: Allergy or intolerance to aspirin or P2Y12 inhibitors.
- Liver Disease: Patients with cirrhosis or significant liver dysfunction.
- Limited Life Expectancy: Patients with a life expectancy of less than 12 months due to other non-cardiac conditions.
- Other Medical Conditions: Any condition that might interfere with adherence to the study protocol or follow-up schedule.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Vietnam1 site
University Medical Center of Ho Chi Minh City
Ho Chi Minh City, 70000
Vu H Vu, MD, PhD, +84908431304, vu.vh@umc.edu.vn
About this study
Official title: Efficacy and Safety of Shortening Dual Antiplatelet Therapy Duration with IVUS Guidance in PCI Patients: a Multicenter, Randomized Controlled Trial
This study is designed to assess the efficacy and safety of de-escalating dual antiplatelet therapy (DAPT) at 1 month compared to the standard 12 months of therapy in patients undergoing percutaneous coronary intervention (PCI) guided by intravascular ultrasound (IVUS). The main outcomes measured will include major adverse cardiovascular and cerebrovascular events (NACCE), bleeding events, and target vessel failure (TVF). The goal is to evaluate whether a shorter duration of DAPT is non-inferior to the standard 12-month regimen in preventing ischemic events while reducing the incidence of bleeding.
Read the detailed description
This multicenter, double-blind, randomized controlled trial will evaluate the clinical outcomes of DAPT de-escalation at 1 month compared to 12 months, in patients who have undergone PCI with drug-eluting stent (DES) implantation. The study aims to optimize post-PCI treatment duration while reducing associated risks such as bleeding complications. Intravascular ultrasound (IVUS) will be used to guide stent placement and optimize results, especially in high-risk, complex cases.
Participants will be randomly assigned to two groups:
- One month of DAPT, followed by monotherapy with a P2Y12 inhibitor.
- Standard 12 months of DAPT. Patients will be followed for 12 months after the intervention to track cardiovascular events, bleeding complications, and overall safety.
- Conditions
- Coronary Arterial Disease (CAD), Percutaneous Coronary Intervention (PCI), Intravascular Ultrasound, Dual Antiplatelet Therapy
- Being tested
- DAPT de-escalation
- Keywords
- Shortening DAPT duration, Intravascular Ultrasound (IVUS), Percutaenous Coronary Intervention (PCI), Coronary Arterial Disease (CAD)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DAPT de-escalationDrug
Patients in this group will receive DAPT (aspirin and a P2Y12 inhibitor) for 1 month, followed by monotherapy with a P2Y12 inhibitor for the remaining 11 months.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (1-Month DAPT): DAPT De-escalation (Intervention Group) | Experimental | Patients in this group will receive DAPT (aspirin and a P2Y12 inhibitor) for 1 month, followed by monotherapy with a P2Y12 inhibitor for the remaining 11 months. Receives: Drug: DAPT de-escalation |
| Group 2 (12-Month DAPT): Standard DAPT (Control Group) | No intervention | Patients in this group will continue with DAPT (aspirin and a P2Y12 inhibitor) for the full 12 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Net Adverse Cardiovascular and Cerebrovascular Events (NACCE) within 12 Months Post-PCI
NACCE is a composite of major adverse cardiovascular events (MACEs) and cerebrovascular events, and any significant bleeding event (classified according to BARC 2-5). Cumulative risk of NACCE will be compared between the 1-month DAPT and 12-month DAPT groups.
Measured: 12 months of enrollment
Secondary outcomes (4)
12-month Target Vessel Failure (TVF) Rate
TVF is defined as a composite of target vessel myocardial infarction (TVMI), target vessel revascularization (TVR), or cardiovascular death related to the target vessel. Cumulative incidence of TVF will be compared between each treatment group.
Measured: 12 months of enrollment
12-month Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)
MACCE includes cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, and clinically-driven revascularization or definite stent thrombosis.
Cumulative risk of MACCE will be compared between the 1-month DAPT and 12-month DAPT groups.
Measured: 12 months of enrollment
Major Bleeding Events Classified by BARC (Bleeding Academic Research Consortium) Scale
To compare the rate of significant bleeding, classified according to the Bleeding Academic Research Consortium (BARC) types 2 to 5, between the two groups.
Measured: 12 months of enrollment
Clinical Characteristics of PCI Patients at Baseline (Descriptive Analysis of Demographics and Clinical Data)
This outcome measure will include a detailed analysis of the clinical characteristics of patients undergoing PCI. The data will include demographics (age, gender), cardiovascular risk factors (diabetes, hypertension, smoking status), previous cardiovascular events, and other relevant clinical history such as comorbidities. Data will be summarized as means (for continuous variables like age) or percentages (for categorical variables like gender and risk factors). This measure aims to provide a baseline comparison between the two study groups (1-month DAPT vs. 12-month DAPT)
Measured: 12 months of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2024
- Study start1 Mar 2025 (estimated)
- Primary completion1 Mar 2028 (estimated)
- Study completion1 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Arterial Disease (CAD)Studies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 3,566 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Ho Chi Minh City (UMC)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vu Hoang Vu, University of Medicine and Pharmacy at Ho Chi Minh City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06648720
- Sponsor's protocol ID
- SHORTDAPT IVUS Trial
- Acronym
- SHORTDAPT
- Status last verified
- Oct 2024
- First submitted
- 3 Oct 2024
- Last updated
- 18 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Shortening Dual Antiplatelet Therapy Duration with IVUS Guidance in PCI Patients: a Multicenter, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06648720
- Acronym / sponsor ID
- SHORTDAPT / SHORTDAPT IVUS Trial
- Conditions
- Coronary Arterial Disease (CAD), Percutaneous Coronary Intervention (PCI), Intravascular Ultrasound, Dual Antiplatelet Therapy
- Keywords
- Shortening DAPT duration, Intravascular Ultrasound (IVUS), Percutaenous Coronary Intervention (PCI), Coronary Arterial Disease (CAD)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 3,566 participants (estimated)
- Lead sponsor
- University Medical Center Ho Chi Minh City (UMC)University, hospital or other
- Collaborators
- University of Medicine and Pharmacy at Ho Chi Minh City
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- 1 Mar 2029 (estimated)
- First posted
- 18 Oct 2024 (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.
This study is designed to assess the efficacy and safety of de-escalating dual antiplatelet therapy (DAPT) at 1 month compared to the standard 12 months of therapy in patients undergoing percutaneous coronary intervention (PCI) guided by intravascular ultrasound (IVUS). The main outcomes measured will include major adverse cardiovascular and cerebrovascular events (NACCE), bleeding events, and target vessel failure (TVF). The goal is to evaluate whether a shorter duration of DAPT is non-inferior to the standard 12-month regimen in preventing ischemic events while reducing the incidence of bleeding.
Detailed description
This multicenter, double-blind, randomized controlled trial will evaluate the clinical outcomes of DAPT de-escalation at 1 month compared to 12 months, in patients who have undergone PCI with drug-eluting stent (DES) implantation. The study aims to optimize post-PCI treatment duration while reducing associated risks such as bleeding complications. Intravascular ultrasound (IVUS) will be used to guide stent placement and optimize results, especially in high-risk, complex cases.
Participants will be randomly assigned to two groups:
- One month of DAPT, followed by monotherapy with a P2Y12 inhibitor.
- Standard 12 months of DAPT. Patients will be followed for 12 months after the intervention to track cardiovascular events, bleeding complications, and overall safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 (1-Month DAPT): DAPT De-escalation (Intervention Group) | Experimental | Drug: DAPT de-escalationPatients in this group will receive DAPT (aspirin and a P2Y12 inhibitor) for 1 month, followed by monotherapy with a P2Y12 inhibitor for the remaining 11 months. |
| Group 2 (12-Month DAPT): Standard DAPT (Control Group) | No intervention | –Patients in this group will continue with DAPT (aspirin and a P2Y12 inhibitor) for the full 12 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients aged 18 years or older.
- Patients undergoing percutaneous coronary intervention (PCI) with drug-eluting stents (DES).
- Patients with the following clinical indications for PCI:
- Patients who agree to participate and provide informed consent.
Key exclusion criteria (11 listed)
- Inability to Provide Informed Consent: Patients who are unable or unwilling to provide consent.
- Neurological Complications: Stroke or any permanent neurological deficits within the last 3 months.
- Coronary Artery Bypass Graft Surgery: History of CABG surgery.
- Planned Surgery: Patients who have surgeries planned within the next 12 months.
- Severe Chronic Kidney Disease: Patients with an estimated glomerular filtration rate (eGFR) of less than 20 ml/min/1.73 m² or patients on dialysis.
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 |
|---|---|---|
| DAPT de-escalationPatients in this group will receive DAPT (aspirin and a P2Y12 inhibitor) for 1 month, followed by monotherapy with a P2Y12 inhibitor for the remaining 11 months. | Drug | Group 1 (1-Month DAPT): DAPT De-escalation (Intervention Group) |
Primary outcome
Net Adverse Cardiovascular and Cerebrovascular Events (NACCE) within 12 Months Post-PCI
Time frame: 12 months of enrollment
NACCE is a composite of major adverse cardiovascular events (MACEs) and cerebrovascular events, and any significant bleeding event (classified according to BARC 2-5). Cumulative risk of NACCE will be compared between the 1-month DAPT and 12-month DAPT groups.
4 secondary outcomes
12-month Target Vessel Failure (TVF) Rate
Time frame: 12 months of enrollment
12-month Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)
Time frame: 12 months of enrollment
Major Bleeding Events Classified by BARC (Bleeding Academic Research Consortium) Scale
Time frame: 12 months of enrollment
Clinical Characteristics of PCI Patients at Baseline (Descriptive Analysis of Demographics and Clinical Data)
Time frame: 12 months of enrollment
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 18 Oct 2024.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DAPT de-escalation in people with Coronary Arterial Disease (CAD) and Percutaneous Coronary Intervention (PCI), run by University Medical Center Ho Chi Minh City (UMC) at 1 site in Vietnam.
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 7 inclusion and 11 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: opening soon, as of the sponsor's last update on 18 Oct 2024. 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 Vietnam. 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?
Contact Vu H Vu, MD, PhD (+84908431304, vu.vh@umc.edu.vn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Net Adverse Cardiovascular and Cerebrovascular Events (NACCE) within 12 Months Post-PCI (time frame: 12 months of enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Oct 2024.