Acute Coronary SyndromePhase 4NCT02041650
Paradigm Shift in the Treatment of Patients With ACS
A Phase 4 study testing Ticagrelor in people with Acute Coronary Syndrome, run by Yu Bo at 1 site in China.
Trial summary
This protocol describes a pilot study intended to test the hypothesis that patients with acute coronary syndrome (ACS) caused by plaque erosion can be stabilized by effective antithrombotic treatment without stent implantation, thereby avoiding both early and late complications related to percutaneous coronary… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- Ticagrelor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteChina
- Study dates
- Aug 2014to Apr 2017
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or non-pregnant women >18 years of age and < 75 years of age
- Patients undergo cardiac catheterization for ACS. Patients with STEMI, NSTEMI, and UAP will be included. STEMI will be defined as continuous chest pain for >30 minutes, arrival at the hospital within 12 hours from chest pain onset, ST-segment elevation >0.1 mV in at least two contiguous leads, or new left bundle-branch block on the 12-lead electrocardiogram (ECG), and elevated cardiac markers (troponin T/I or creatine kinase-MB). NSTEMI will be defined as a progressive crescendo pattern of angina or angina at rest, in the absence of ST-segment elevation on the 12-lead ECG, with elevated cardiac markers. UAP will be defined as new onset angina, progressive crescendo pattern of angina, or angina at rest.
- Culprit lesion located in a native coronary artery
- TIMI flow grade 3 and diameter stenosis < 70% on angiogram
- Definite erosion defined by OCT
- Patients able to provide written informed consent
Who cannot join
- Left ventricular ejection fraction < 30%.
- Life expectancy < 1 year.
- Contraindication to the contrast media.
- Creatinine level > 2.0 mg/dL or end-stage kidney disease.
- Serious liver dysfunction.
- Patients with hemodynamic or electrical instability (including shock).
- Any contraindication against the use of ticagrelor.
- Investigator considers the patient is not suitable.
Trial locations and contacts
1 site in 1 country.
China1 site
The 2nd Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150086
About this study
Official title: Plaque Erosion: A New in Vivo Diagnosis and Paradigm Shift in the Treatment of Patients With Acute Coronary Syndrome
This protocol describes a pilot study intended to test the hypothesis that patients with acute coronary syndrome (ACS) caused by plaque erosion can be stabilized by effective antithrombotic treatment without stent implantation, thereby avoiding both early and late complications related to percutaneous coronary intervention (PCI).
- Conditions
- Acute Coronary Syndrome
- Being tested
- Ticagrelor
- 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.
TicagrelorDrug
| Study group | Role | What they receive |
|---|---|---|
| Patients with ACS treated medically | Other | Not described Receives: Drug: Ticagrelor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of thrombus burden by OCT
The efficacy will be assessed by 50% reduction in thrombus burden by OCT at 1 month.
Measured: 30 days
Secondary outcomes (1)
Cardiovascular adverse events
In patients treated conservatively, the safety objectives are to evaluate the occurrence of any adverse events during1 month follow up (re-infarction, re-hospitalization, revascularization by PCI or CABG, cardiac death, stoke, and major bleeding).
Measured: 30 days 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 posted22 Jan 2014 (estimated)
- Study startAug 2014
- Primary completionApr 2016
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yu Bo
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts General Hospital
- Responsible party
- Sponsor-investigator, Yu Bo, Harbin Medical University
- Investigators
- Bo Yu, MD, PhD, Principal investigator, The Second Affiliated Hospital of Harbin Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02041650
- Sponsor's protocol ID
- ISSBRIL0186
- Other IDs
- ISSBRIL0186
- Status last verified
- Jul 2018
- First submitted
- 17 Jan 2014
- Last updated
- 11 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Seegers LM, Yeh DD, Wood MJ, Yonetsu T, Minami Y, Araki M, Nakajima A, Yuki H, Ako J, Soeda T, Kurihara O, Higuma T, Kimura S, Adriaenssens T, Nef HM, Lee H, McNulty I, Sugiyama T, Kakuta T, Jang IK. Cardiovascular Risk Factors and Culprit Plaque Characteristics in Women With Acute Coronary Syndromes. Am J Cardiol. 2023 Nov 15;207:13-20. doi: 10.1016/j.amjcard.2023.08.152. Epub 2023 Sep 16.
PubMed 37722196Zeng M, Zhao C, Bao X, Liu M, He L, Xu Y, Meng W, Qin Y, Weng Z, Yi B, Zhang D, Wang S, Luo X, Lv Y, Chen X, Sun Q, Feng X, Gao Z, Sun Y, Demuyakor A, Li J, Hu S, Guagliumi G, Mintz GS, Jia H, Yu B. Clinical Characteristics and Prognosis of MINOCA Caused by Atherosclerotic and Nonatherosclerotic Mechanisms Assessed by OCT. JACC Cardiovasc Imaging. 2023 Apr;16(4):521-532. doi: 10.1016/j.jcmg.2022.10.023. Epub 2022 Dec 14.
PubMed 36648054Kim HO, Jiang B, Poon EKW, Thondapu V, Kim CJ, Kurihara O, Araki M, Nakajima A, Mamon C, Dijkstra J, Lee H, Ooi A, Barlis P, Jang IK. High endothelial shear stress and stress gradient at plaque erosion persist up to 12 months. Int J Cardiol. 2022 Jun 15;357:1-7. doi: 10.1016/j.ijcard.2022.03.035. Epub 2022 Mar 16.
PubMed 35306029Araki M, Yonetsu T, Kurihara O, Nakajima A, Lee H, Soeda T, Minami Y, Higuma T, Kimura S, Takano M, Yan BP, Adriaenssens T, Boeder NF, Nef HM, Kim CJ, McNulty I, Crea F, Kakuta T, Jang IK. Age and Phenotype of Patients With Plaque Erosion. J Am Heart Assoc. 2021 Oct 5;10(19):e020691. doi: 10.1161/JAHA.120.020691. Epub 2021 Sep 25.
PubMed 34569250Xing L, Yamamoto E, Sugiyama T, Jia H, Ma L, Hu S, Wang C, Zhu Y, Li L, Xu M, Liu H, Bryniarski K, Hou J, Zhang S, Lee H, Yu B, Jang IK. EROSION Study (Effective Anti-Thrombotic Therapy Without Stenting: Intravascular Optical Coherence Tomography-Based Management in Plaque Erosion): A 1-Year Follow-Up Report. Circ Cardiovasc Interv. 2017 Dec;10(12):e005860. doi: 10.1161/CIRCINTERVENTIONS.117.005860.
PubMed 29246916
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plaque Erosion: A New in Vivo Diagnosis and Paradigm Shift in the Treatment of Patients With Acute Coronary Syndrome
- ClinicalTrials.gov ID
- NCT02041650
- Acronym / sponsor ID
- ISSBRIL0186
- Conditions
- Acute Coronary Syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Yu BoUniversity, hospital or other
- Collaborators
- Massachusetts General Hospital
- Study start
- Aug 2014
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 22 Jan 2014 (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.
This protocol describes a pilot study intended to test the hypothesis that patients with acute coronary syndrome (ACS) caused by plaque erosion can be stabilized by effective antithrombotic treatment without stent implantation, thereby avoiding both early and late complications related to percutaneous coronary intervention (PCI).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with ACS treated medically | Other | Drug: Ticagrelor |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Men or non-pregnant women >18 years of age and < 75 years of age
- Patients undergo cardiac catheterization for ACS. Patients with STEMI, NSTEMI, and UAP will be included. STEMI will be defined as continuous chest pain for >30 minutes, arrival at the hospital within 12 hours from chest pain onset, ST-segment elevation >0.1 mV in at least two contiguous leads, or new left bundle-branch block on the 12-lead electrocardiogram (ECG), and elevated cardiac markers (troponin T/I or creatine kinase-MB). NSTEMI will be defined as a progressive crescendo pattern of angina or angina at rest, in the absence of ST-segment elevation on the 12-lead ECG, with elevated cardiac markers. UAP will be defined as new onset angina, progressive crescendo pattern of angina, or angina at rest.
- Culprit lesion located in a native coronary artery
- TIMI flow grade 3 and diameter stenosis < 70% on angiogram
- Definite erosion defined by OCT
Key exclusion criteria (8 listed)
- Left ventricular ejection fraction < 30%.
- Life expectancy < 1 year.
- Contraindication to the contrast media.
- Creatinine level > 2.0 mg/dL or end-stage kidney disease.
- Serious liver dysfunction.
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 |
|---|---|---|
| Ticagrelor | Drug | Patients with ACS treated medically |
Primary outcome
Reduction of thrombus burden by OCT
Time frame: 30 days
The efficacy will be assessed by 50% reduction in thrombus burden by OCT at 1 month.
1 secondary outcome
Cardiovascular adverse events
Time frame: 30 days and 12 months
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 11 Jul 2018.
- Derived from this study: PubMed 37722196Seegers LM, Yeh DD, Wood MJ, Yonetsu T, Minami Y, Araki M, Nakajima A, Yuki H, Ako J, Soeda T, Kurihara O, Higuma T, Kimura S, Adriaenssens T, Nef HM, Lee H, McNulty I, Sugiyama T, Kakuta T, Jang IK. Cardiovascular Risk Factors and Culprit Plaque Characteristics in Women With Acute Coronary Syndromes. Am J Cardiol. 2023 Nov 15;207:13-20. doi: 10.1016/j.amjcard.2023.08.152. Epub 2023 Sep 16.
- Derived from this study: PubMed 36648054Zeng M, Zhao C, Bao X, Liu M, He L, Xu Y, Meng W, Qin Y, Weng Z, Yi B, Zhang D, Wang S, Luo X, Lv Y, Chen X, Sun Q, Feng X, Gao Z, Sun Y, Demuyakor A, Li J, Hu S, Guagliumi G, Mintz GS, Jia H, Yu B. Clinical Characteristics and Prognosis of MINOCA Caused by Atherosclerotic and Nonatherosclerotic Mechanisms Assessed by OCT. JACC Cardiovasc Imaging. 2023 Apr;16(4):521-532. doi: 10.1016/j.jcmg.2022.10.023. Epub 2022 Dec 14.
- Derived from this study: PubMed 35306029Kim HO, Jiang B, Poon EKW, Thondapu V, Kim CJ, Kurihara O, Araki M, Nakajima A, Mamon C, Dijkstra J, Lee H, Ooi A, Barlis P, Jang IK. High endothelial shear stress and stress gradient at plaque erosion persist up to 12 months. Int J Cardiol. 2022 Jun 15;357:1-7. doi: 10.1016/j.ijcard.2022.03.035. Epub 2022 Mar 16.
- Derived from this study: PubMed 34569250Araki M, Yonetsu T, Kurihara O, Nakajima A, Lee H, Soeda T, Minami Y, Higuma T, Kimura S, Takano M, Yan BP, Adriaenssens T, Boeder NF, Nef HM, Kim CJ, McNulty I, Crea F, Kakuta T, Jang IK. Age and Phenotype of Patients With Plaque Erosion. J Am Heart Assoc. 2021 Oct 5;10(19):e020691. doi: 10.1161/JAHA.120.020691. Epub 2021 Sep 25.
- Derived from this study: PubMed 29246916Xing L, Yamamoto E, Sugiyama T, Jia H, Ma L, Hu S, Wang C, Zhu Y, Li L, Xu M, Liu H, Bryniarski K, Hou J, Zhang S, Lee H, Yu B, Jang IK. EROSION Study (Effective Anti-Thrombotic Therapy Without Stenting: Intravascular Optical Coherence Tomography-Based Management in Plaque Erosion): A 1-Year Follow-Up Report. Circ Cardiovasc Interv. 2017 Dec;10(12):e005860. doi: 10.1161/CIRCINTERVENTIONS.117.005860.
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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.
Bo Yu, MD, PhD principal investigator
The Second Affiliated Hospital of Harbin Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ticagrelor in people with Acute Coronary Syndrome, run by Yu Bo 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 6 inclusion and 8 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 11 Jul 2018. 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.
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?
Reduction of thrombus burden by OCT (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 NCT02041650, which also lists 5 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 11 Jul 2018.