Immune Thrombocytopenic PurpuraITP with CADNCT07426107
Development and Prospective Validation of an AI Model for Prognosis in ITP Patients Undergoing Coronary Revascularization
An observational study of Immune Thrombocytopenic Purpura and Coronary Artery Disease, run by Xiao Hui Zhang.
Trial summary
This study employs a dual-cohort design to develop and validate a prognostic model for Major Adverse Cardiovascular Events (MACE) following revascularization in immune thrombocytopenia (ITP) patients with Coronary Artery Disease (CAD). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Immune Thrombocytopenic Purpura, Coronary Artery Disease
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- 25 Feb 2026to 25 Feb 2029
- Phase
- Observational
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Retrospective Development/Training Cohort: This cohort will include eligible patients identified from the past medical records of participating centers. Data on their treatment (revascularization or medical therapy) and long-term outcomes will be collected retrospectively. This cohort serves primarily for predictor identification and initial model development/training. Prospective Validation Cohort: This cohort will consist of consecutive, eligible patients newly identified at participating centers following study initiation. They will be managed according to standard clinical practice and followed forward in time for outcome events. This cohort is dedicated to the external validation and performance testing of the prediction model derived from the retrospective cohort.
Who may be able to join
- Age ≥ 18 years.
- Diagnosis of primary Immune Thrombocytopenia (ITP) according to international working group criteria.
- Diagnosis of Coronary Artery Disease (stable angina or Acute Coronary Syndrome) confirmed by coronary angiography.
- The diagnosis of ITP must be established and documented prior to the diagnosis of CAD.
- Capable of providing informed consent (for prospective enrollment and data collection).
Who cannot join
- Secondary causes of thrombocytopenia (e.g., drug-induced, hematologic malignancy, hypersplenism, liver disease).
- Conditions requiring long-term therapeutic anticoagulation (e.g., atrial fibrillation, mechanical heart valve).
- Life expectancy less than 1 year due to non-cardiovascular disease.
- Inability to comply with follow-up.
- Inability to give informed consent.
- Pregnancy or breastfeeding.
- A history of Type 2 Myocardial Infarction prior to the index treatment decision.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: An Artificial Intelligence-Enhanced Longitudinal Cohort Study to Optimize Revascularization Decisions in Patients With Coronary Artery Disease and Immune Thrombocytopenia (The ITP-CAD AI-REVASC Study)
This study employs a dual-cohort design to develop and validate a prognostic model for Major Adverse Cardiovascular Events (MACE) following revascularization in immune thrombocytopenia (ITP) patients with Coronary Artery Disease (CAD). The model will be developed and trained using a retrospective multi-center cohort (development/training cohort). Its performance will then be prospectively validated in a separate, consecutively enrolled prospective cohort (validation cohort). The goal is to create an AI-based tool to assist in personalized risk assessment and decision-making for this high-risk population.
Read the detailed description
Study Design: This is a dual-phase, multi-center observational study. Phase 1 (Retrospective Cohort): A retrospective cohort will serve as the development and training set. Data from eligible patients treated in the past will be collected to identify predictors and develop the initial AI prediction model.
Phase 2 (Prospective Cohort): A prospective, observational cohort will serve as the validation set. Consecutively eligible patients will be enrolled and followed forward in time. The model derived from Phase 1 will be applied to this cohort to evaluate its predictive accuracy and clinical utility.
Treatment Groups: Within both cohorts, patients will be categorized based on actual clinical care:
- Revascularization Group: Patients undergoing PCI or CABG.
- Medical Therapy Group: Patients managed with guideline-directed medical therapy alone.
Objective: To compare MACE risk between groups and to develop and validate a model predicting MACE specifically in the revascularization group.
- Keywords
- immune thrombocytopenia, coronary artery disease, coronary revascularization, prognostic model, MACE
- Medical subject headings
- Purpura, Thrombocytopenic, Idiopathic, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Revascularization Group | Coronary artery bypass grafting (CABG) or Percutaneous coronary intervention (PCI) according to standard of care. | |
| Medical Therapy Group | Guideline-directed medical therapy without revascularization |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-month incidence of Major Adverse Cardiovascular Events (MACE)
MACE is a composite endpoint defined as the occurrence of any of the following: all-cause mortality, non-fatal myocardial infarction [MI], urgent coronary revascularization [CRV] and ischemic stroke. The time frame for assessment is from the date of CAD diagnosis (index date) until 1 month of follow-up.
Measured: from the date of CAD diagnosis (index date) until 1 month of follow-up
1-year incidence of Major Adverse Cardiovascular Events (MACE)
MACE is a composite endpoint defined as the occurrence of any of the following: all-cause mortality, non-fatal myocardial infarction [MI], urgent coronary revascularization [CRV] and ischemic stroke. The time frame for assessment is from the date of diagnosis of CAD (index date) until 1 year of follow-up.
Measured: from the date of CAD diagnosis (index date) until 1 year of follow-up
Secondary outcomes (5)
key predictors of adverse outcomes following revascularization
Identification of independent predictors for MACE in the revascularization group using a multivariate Cox proportional hazards regression model with stepwise selection or Lasso regularization. The model will include candidate clinical variables such as platelet count, type of CAD, comorbidities, and medication use. For each final predictor selected, the Hazard Ratio (HR), 95% confidence interval, and p-value will be reported. MACE is defined as a composite of all-cause death, non-fatal myocardial infarction, urgent coronary revascularization and ischemic stroke.
Measured: from the date of CAD diagnosis (index date) until 1 month and 1 year of follow-up
BARC type ≥2 bleeding event
clinical-related bleeding with a BARC type ≥2 bleeding event
Measured: from the date of CAD diagnosis (index date) until 1 month and 1 year of follow-up
overall bleeding event
the bleeding event identified according to the BARC standardized bleeding Criteria
Measured: from the date of CAD diagnosis (index date) until 1 month and 1 year of follow-up
Hospitalization for CAD within 1 year.
Hospitalization for CAD within 1 year.
Measured: from the date of CAD diagnosis (index date) until 1 year of follow-up
1-year overall survival
overall survival from the date of CAD diagnosis (index date) until 1 year of follow-up
Measured: from the date of CAD diagnosis (index date) until 1 year of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study start25 Feb 2026 (estimated)
- Primary completion25 Feb 2028 (estimated)
- Study completion25 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune Thrombocytopenic PurpuraStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiao Hui Zhang
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese Academy of Medical Sciences, Fuwai Hospital, Beijing Anzhen Hospital, Peking University Third Hospital, Chinese PLA General Hospital, Peking Union Medical College
- Responsible party
- Sponsor-investigator, Xiao Hui Zhang, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07426107
- Sponsor's protocol ID
- The ITP-CAD AI-REVASC Study
- Acronym
- ITP with CAD
- Status last verified
- Feb 2026
- First submitted
- 17 Dec 2025
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Artificial Intelligence-Enhanced Longitudinal Cohort Study to Optimize Revascularization Decisions in Patients With Coronary Artery Disease and Immune Thrombocytopenia (The ITP-CAD AI-REVASC Study)
- ClinicalTrials.gov ID
- NCT07426107
- Acronym / sponsor ID
- ITP with CAD / The ITP-CAD AI-REVASC Study
- Keywords
- immune thrombocytopenia, coronary artery disease, coronary revascularization, prognostic model, MACE
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Xiao Hui ZhangUniversity, hospital or other
- Collaborators
- Chinese Academy of Medical Sciences, Fuwai Hospital, Beijing Anzhen Hospital, Peking University Third Hospital, Chinese PLA General Hospital, Peking Union Medical College
- Study start
- 25 Feb 2026 (estimated)
- Primary completion
- 25 Feb 2028 (estimated)
- Study completion
- 25 Feb 2029 (estimated)
- First posted
- 23 Feb 2026 (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 employs a dual-cohort design to develop and validate a prognostic model for Major Adverse Cardiovascular Events (MACE) following revascularization in immune thrombocytopenia (ITP) patients with Coronary Artery Disease (CAD). The model will be developed and trained using a retrospective multi-center cohort (development/training cohort). Its performance will then be prospectively validated in a separate, consecutively enrolled prospective cohort (validation cohort). The goal is to create an AI-based tool to assist in personalized risk assessment and decision-making for this high-risk population.
Detailed description
Study Design: This is a dual-phase, multi-center observational study. Phase 1 (Retrospective Cohort): A retrospective cohort will serve as the development and training set. Data from eligible patients treated in the past will be collected to identify predictors and develop the initial AI prediction model.
Phase 2 (Prospective Cohort): A prospective, observational cohort will serve as the validation set. Consecutively eligible patients will be enrolled and followed forward in time. The model derived from Phase 1 will be applied to this cohort to evaluate its predictive accuracy and clinical utility.
Treatment Groups: Within both cohorts, patients will be categorized based on actual clinical care:
- Revascularization Group: Patients undergoing PCI or CABG.
- Medical Therapy Group: Patients managed with guideline-directed medical therapy alone.
Objective: To compare MACE risk between groups and to develop and validate a model predicting MACE specifically in the revascularization group.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Revascularization Group | – | –Coronary artery bypass grafting (CABG) or Percutaneous coronary intervention (PCI) according to standard of care. |
| Medical Therapy Group | – | –Guideline-directed medical therapy without revascularization |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Retrospective Development/Training Cohort: This cohort will include eligible patients identified from the past medical records of participating centers. Data on their treatment (revascularization or medical therapy) and long-term outcomes will be collected retrospectively. This cohort serves primarily for predictor identification and initial model development/training. Prospective Validation Cohort: This cohort will consist of consecutive, eligible patients newly identified at participating centers following study initiation. They will be managed according to standard clinical practice and followed forward in time for outcome events. This cohort is dedicated to the external validation and performance testing of the prediction model derived from the retrospective cohort.
Key inclusion criteria (5 listed)
- Age ≥ 18 years.
- Diagnosis of primary Immune Thrombocytopenia (ITP) according to international working group criteria.
- Diagnosis of Coronary Artery Disease (stable angina or Acute Coronary Syndrome) confirmed by coronary angiography.
- The diagnosis of ITP must be established and documented prior to the diagnosis of CAD.
- Capable of providing informed consent (for prospective enrollment and data collection).
Key exclusion criteria (7 listed)
- Secondary causes of thrombocytopenia (e.g., drug-induced, hematologic malignancy, hypersplenism, liver disease).
- Conditions requiring long-term therapeutic anticoagulation (e.g., atrial fibrillation, mechanical heart valve).
- Life expectancy less than 1 year due to non-cardiovascular disease.
- Inability to comply with follow-up.
- Inability to give informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
1-month incidence of Major Adverse Cardiovascular Events (MACE)
Time frame: from the date of CAD diagnosis (index date) until 1 month of follow-up
MACE is a composite endpoint defined as the occurrence of any of the following: all-cause mortality, non-fatal myocardial infarction [MI], urgent coronary revascularization [CRV] and ischemic stroke. The time frame for assessment is from the date of CAD diagnosis (index date) until 1 month of follow-up.
1-year incidence of Major Adverse Cardiovascular Events (MACE)
Time frame: from the date of CAD diagnosis (index date) until 1 year of follow-up
MACE is a composite endpoint defined as the occurrence of any of the following: all-cause mortality, non-fatal myocardial infarction [MI], urgent coronary revascularization [CRV] and ischemic stroke. The time frame for assessment is from the date of diagnosis of CAD (index date) until 1 year of follow-up.
5 secondary outcomes
key predictors of adverse outcomes following revascularization
Time frame: from the date of CAD diagnosis (index date) until 1 month and 1 year of follow-up
BARC type ≥2 bleeding event
Time frame: from the date of CAD diagnosis (index date) until 1 month and 1 year of follow-up
overall bleeding event
Time frame: from the date of CAD diagnosis (index date) until 1 month and 1 year of follow-up
Hospitalization for CAD within 1 year.
Time frame: from the date of CAD diagnosis (index date) until 1 year of follow-up
1-year overall survival
Time frame: from the date of CAD diagnosis (index date) until 1 year of follow-up
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 23 Feb 2026.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Immune Thrombocytopenic Purpura and Coronary Artery Disease, run by Xiao Hui Zhang.
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 5 inclusion and 7 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 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Jin Wu (010-17888838056, wujin1996@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-month incidence of Major Adverse Cardiovascular Events (MACE) (time frame: from the date of CAD diagnosis (index date) until 1 month of follow-up). The study lists 2 primary outcomes in all. 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 23 Feb 2026.