Antiplatelet DrugsPhase 4ASSURE-DESNCT02797548
Perioperative Antiplatelet Therapy in Patients With Drug-eluting Stent Undergoing Noncardiac Surgery
A Phase 4 study testing Aspirin only and No antiplatelet therapy in people with Antiplatelet Drugs, run by Jung-min Ahn at 35 sites in 3 countries.
Trial summary
The purpose of this study is to evaluate the safety and effectiveness of perioperative antiplatelet therapy in patients with drug-eluting stent undergoing non-cardiac surgery. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Antiplatelet Drugs
- What is being tested?
- Aspirin only and No antiplatelet therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,010 participants
- Where
- 35 sitesin 3 countries
- Study dates
- 16 Mar 2017to 31 May 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Planned non-cardiac surgery at least after 12 months of implantation of drug eluting stent
- Low or intermediate risk level surgery
- Written informed consent
Who cannot join
- Acute coronary syndrome within 1 month
- Heart failure NYHA III to IV
- Contraindication to Aspirin
- On anticoagulant therapy
- Emergent surgery
- Cardiac surgery
Show all 9Show fewer
- High bleeding risk surgeries, e.g., Intra-cranial surgery, Intra-spinal surgery, Retinal surgery
- Pregnancy or breast-feeding
- Life expectancy less than 1year
Trial locations and contacts
35 sites in 3 countries.
35 sites in 3 countries
South Korea32 sites
Hallym University Sacred Heart Hospital
Anyang
Soon Chun Hyang University Hospital Bucheon
Bucheon-si
Dong-A Medical Center
Busan
Pusan National University Yangsan Hospital
Busan
Soon Chun Hyang University Hospital Cheonan
Cheonan
Chungbuk National University Hospital
Cheonju
Gangwon National Univ. Hospital
Chuncheon
Keimyung University Dongsan Medical Center
Daegu
Yeungnam University Medical Center
Daegu
Chungnam National University Hospital
Daejeon
The Catholic University of Korea, Daejeon St. Mary's Hosptial
Daejeon
Gangneung Asan Hospital
Gangneung
Wonkwang University Sanbon Hospital
Gunpo
Chonnam National University Hospital
Gwangju
Chosun University Hospital
Gwangju
Wonkwang University Hospital
Iksan
National Health Insurance Service Ilsan Hospital
Ilsan
Pusan National University Hospital
Pusan
Sejong Chungnam National University Hospital
Sejong
Asan Medical Center
Seoul, Songpa-gu, 138-736
Ewha Womans University Medical Center
Seoul
Gangnam Severance Hospital
Seoul
Hallym University Kangnam Sacred Heart Hospital
Seoul
Hanyang University Seoul Hospital
Seoul
Kangbuk Samsung Hospital
Seoul
Korea University Anam Hospital
Seoul
Korea University Guro Hospital
Seoul
Seoul National University Hospital
Seoul
Severance Hospital
Seoul
The Catholic University of Korea, Eunpyeong St. Mary's Hospital
Seoul
Wonju Severance Christian Hospital
Wŏnju
Yongin Severance Hospital
Yŏngin
Turkey (Türkiye)2 sites
Bagcilar Education and Training Hospital
Istanbul
SBU Bakirkoy Dr.Sadi Konuk Education and Training Hospital
Istanbul
About this study
The purpose of this study is to evaluate the safety and effectiveness of perioperative antiplatelet therapy in patients with drug-eluting stent undergoing non-cardiac surgery.
Read the detailed description
Subjects who can not be randomized due to any reason will be enrolled at observational group.
- Conditions
- Antiplatelet Drugs
- Being tested
- Aspirin only, No antiplatelet therapy
- Keywords
- drug-eluting stent, antiplatelet therapy, noncardiac surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aspirin onlyDrug
Aspirin only during surgery
No antiplatelet therapyDrug
No antiplatelet therapy will be during surgery
| Study group | Role | What they receive |
|---|---|---|
| Aspirin only | Experimental | Not described Receives: Drug: Aspirin only |
| No antiplatelet therapy | Active comparator | Not described Receives: Drug: No antiplatelet therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The event rate of composite event of all-cause death, stent thrombosis, myocardial infarction, and stroke
A composite endpoint is an endpoint that is a combination of multiple clinical endpoints. An event that is considered to have occurred if any one of several different events is observed.
Measured: 30 days
Secondary outcomes (11)
The event rate of all cause death
Measured: 30 days
The event rate of cardiac death
Measured: 30 days
The event rate of myocardial infarction
Measured: 30 days
The event rate of stroke
Measured: 30 days
The event rate of stent thrombosis
Measured: 30 days
The event rate of repeat revascularization
Measured: 30 days
The event rate of life threatening bleeding
Measured: 30 days
The event rate of major bleeding
Measured: 30 days
Quality of life score assessed by the EQ-5D-5L
The EQ-5D-5L essentially consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS).
The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.
Higher score of EQ-5D and EQ VAS means the low quality of life. EQ-5D: the minimum and maximum values are 5 and 25 respectively. EQ VAS: the minimum and maximum values are 0 and 100 respectively.
Measured: 30 days
Quality of life score assessed by Health-related Quality of Life Instrument with 8 Items (HINT-8)
HINT-8 was developed based on 4 health dimensions: physical, mental, social, and positive health dimensions. It consists of climbing stairs, endurance to pain, vitality, working, depression, memory, sleep, and happiness.
Higher score of HINT-8 means the high quality of life. The minimum and maximum values are 0 and 100 respectively if convert to a percentage.
Measured: 30 days
Cost-effective analysis
Cost-effective analysis based on average treatment costs for two perioperative antiplatelet therapy_Aspirin only vs. No antiplatelet therapy_in patients with drug-eluting stent undergoing non-cardiac surgery.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2016 (estimated)
- Study start16 Mar 2017
- Primary completion31 May 2024
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Antiplatelet DrugsStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,010 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jung-min Ahn
- Sponsor type
- University, hospital or other
- Collaborators
- CardioVascular Research Foundation, Korea
- Responsible party
- Sponsor-investigator, Jung-min Ahn, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02797548
- Sponsor's protocol ID
- AMCCV2016-10
- Acronym
- ASSURE-DES
- Status last verified
- Nov 2024
- First submitted
- 8 Jun 2016
- Last updated
- 5 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kang DY, Lee SH, Lee SW, Lee CH, Kim C, Jang JY, Mehta N, Oh JH, Cho YR, Yoon KH, Ahn SG, Lee JH, Cho DK, Kim Y, Kim J, Cho GH, Lee KS, Park H, Vural M, Lim YH, Park KH, Lee BK, Lee JY, Park HW, Yoon YH, Lee JH, Lee SY, Park KW, Kang J, Kim HK, Kang SH, Park JH, Choi IC, Yu CS, Yun SC, Park DW, Hong MK, Park SJ, Kim JS, Ahn JM; ASSURE DES Investigators. Aspirin Monotherapy vs No Antiplatelet Therapy in Stable Patients With Coronary Stents Undergoing Low-to-Intermediate Risk Noncardiac Surgery. J Am Coll Cardiol. 2024 Dec 10;84(24):2380-2389. doi: 10.1016/j.jacc.2024.08.024. Epub 2024 Aug 31.
PubMed 39217573
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Antiplatelet Therapy in Patients With Drug-eluting Stent Undergoing Noncardiac Surgery
- ClinicalTrials.gov ID
- NCT02797548
- Acronym / sponsor ID
- ASSURE-DES / AMCCV2016-10
- Conditions
- Antiplatelet Drugs
- Keywords
- drug-eluting stent, antiplatelet therapy, noncardiac surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,010 participants (actual)
- Lead sponsor
- Jung-min AhnUniversity, hospital or other
- Collaborators
- CardioVascular Research Foundation, Korea
- Study start
- 16 Mar 2017 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 13 Jun 2016 (estimated)
- 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.
The purpose of this study is to evaluate the safety and effectiveness of perioperative antiplatelet therapy in patients with drug-eluting stent undergoing non-cardiac surgery.
Detailed description
Subjects who can not be randomized due to any reason will be enrolled at observational group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aspirin only | Experimental | Drug: Aspirin only |
| No antiplatelet therapy | Active comparator | Drug: No antiplatelet therapy |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Planned non-cardiac surgery at least after 12 months of implantation of drug eluting stent
- Low or intermediate risk level surgery
- Written informed consent
Key exclusion criteria (9 listed)
- Acute coronary syndrome within 1 month
- Heart failure NYHA III to IV
- Contraindication to Aspirin
- On anticoagulant therapy
- Emergent surgery
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 onlyAspirin only during surgery | Drug | Aspirin only |
| No antiplatelet therapyNo antiplatelet therapy will be during surgery | Drug | No antiplatelet therapy |
Primary outcome
The event rate of composite event of all-cause death, stent thrombosis, myocardial infarction, and stroke
Time frame: 30 days
A composite endpoint is an endpoint that is a combination of multiple clinical endpoints. An event that is considered to have occurred if any one of several different events is observed.
11 secondary outcomes
The event rate of all cause death
Time frame: 30 days
The event rate of cardiac death
Time frame: 30 days
The event rate of myocardial infarction
Time frame: 30 days
The event rate of stroke
Time frame: 30 days
The event rate of stent thrombosis
Time frame: 30 days
The event rate of repeat revascularization
Time frame: 30 days
The event rate of life threatening bleeding
Time frame: 30 days
The event rate of major bleeding
Time frame: 30 days
Quality of life score assessed by the EQ-5D-5L
Time frame: 30 days
Quality of life score assessed by Health-related Quality of Life Instrument with 8 Items (HINT-8)
Time frame: 30 days
Cost-effective analysis
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2024.
- Derived from this study: PubMed 39217573Kang DY, Lee SH, Lee SW, Lee CH, Kim C, Jang JY, Mehta N, Oh JH, Cho YR, Yoon KH, Ahn SG, Lee JH, Cho DK, Kim Y, Kim J, Cho GH, Lee KS, Park H, Vural M, Lim YH, Park KH, Lee BK, Lee JY, Park HW, Yoon YH, Lee JH, Lee SY, Park KW, Kang J, Kim HK, Kang SH, Park JH, Choi IC, Yu CS, Yun SC, Park DW, Hong MK, Park SJ, Kim JS, Ahn JM; ASSURE DES Investigators. Aspirin Monotherapy vs No Antiplatelet Therapy in Stable Patients With Coronary Stents Undergoing Low-to-Intermediate Risk Noncardiac Surgery. J Am Coll Cardiol. 2024 Dec 10;84(24):2380-2389. doi: 10.1016/j.jacc.2024.08.024. Epub 2024 Aug 31.
- Individual participant dataSharing planned: Undecided
Related trials for Antiplatelet Drugs
Not yet recruitingPhase 3
TicAgreLor Versus Placebo to Prevent Cerebral ISCHemia in anEuRysmal Low Grade SAH A Double Blinded Randomised Controlled Study
Subarachnoid Hemorrhage, Aneurysmal, Brain Ischemia
RecruitingPhase 4
Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
Acute Coronary Syndromes, STEMI
Recruiting
Algorithm-based Tailoring of Dual Antiplatelet Therapy to Improve Outcomes Following Percutaneous Coronary Interventions
Percutaneous Coronary Intervention, Platelet Aggregation Inhibitors
Enrolling by invitationPhase 3
Selatogrel Outcome Study in Suspected Acute Myocardial Infarction
Acute Myocardial Infarction
Not yet recruiting
1-Month Versus 6-Month Dual Antiplatelet Therapy After Successful Drug-Coated Balloon-Only Percutaneous Coronary Intervention
Coronary Artery Disease (CAD)
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.
The record lists no contact. Use the official record to reach the sponsor.
35 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Aspirin only and No antiplatelet therapy in people with Antiplatelet Drugs, run by Jung-min Ahn at 35 sites in 3 countries.
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 9 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: finished, as of the sponsor's last update on 5 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in South Korea, Turkey (Türkiye), India. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The event rate of composite event of all-cause death, stent thrombosis, myocardial infarction, and stroke (time frame: 30 days). 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 NCT02797548, which also lists 1 linked publication.
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 5 Nov 2024.