Baseline ThrombocytopeniaNCT06223607
Dual Antiplatelet Therapy (DAPT) in Patients With Baseline Thrombocytopenia
An observational study of Baseline Thrombocytopenia, run by Methodist Health System at 1 site in United States.
Trial summary
The use of clopidogrel as part of DAPT will be associated with lower bleeding rates compared to ticagrelor in patients with chronic thrombocytopenia requiring Percutaneous intervention (PCI )with Drug Eluting Stent (DES) or Bare Metal Stint(BMS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Baseline Thrombocytopenia
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Aug 2022to 22 Dec 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study population of 18 years of age ,PCI with either DES or BMS during study time period (April 1, 2018 through July 1 2021) ,Thrombocytopenia on at least one occasion prior to PCI and at least one dose of DAPT post-PCI with aspirin and either clopidogrel or ticagrelor
Who may be able to join
- ≥ 18 years
- PCI with either DES or BMS during study time period (April 1, 2018 through July 1 2021)
- Thrombocytopenia defined as platelet count <100 x103 /µL on at least one occasion prior to PCI
- At least one dose of DAPT post-PCI with aspirin and either clopidogrel or ticagrelor
Who cannot join
- Death within 48 hours post-PCI
- DAPT prior to cardiac catheterization
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Methodist Dallas Medical Center
Dallas, Texas, 75203
Colette Ngo Ndjom, 214-947-4681 ext. 71289, mhsirb@mhd.com
Bethany Brauer, 214-947-4681 ext. 74681, mhsirb@mhd.com
About this study
The use of clopidogrel as part of DAPT will be associated with lower bleeding rates compared to ticagrelor in patients with chronic thrombocytopenia requiring Percutaneous intervention (PCI )with Drug Eluting Stent (DES) or Bare Metal Stint(BMS).
Read the detailed description
Patients with thrombocytopenia are at an increased risk of both bleeding and ischemic events following PCI; however, there is a paucity of data on how to optimally manage these risks. Data indicates that ticagrelor is associated with reduced ischemic outcomes with an accompanying increased risk of bleed in the broader population. This study will assess P2Y12 agent selection in patients with chronic thrombocytopenia to determine if one better balances risks of ischemic and bleeding events following coronary intervention
- Conditions
- Baseline Thrombocytopenia
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of bleeding
To evaluate the difference in bleeding rates in patients with chronic thrombocytopenia maintained on DAPT with clopidogrel compared to patients maintained on DAPT with ticagrelor.
Measured: 1 year
Secondary outcomes (3)
Incidence of ischemic events
number of ischemic events
Measured: 1 year
All-cause mortality
all-cause mortality in patients with chronic thrombocytopenia maintained on DAPT with clopidogrel compared to patients maintained on DAPT with ticagrelor.
Measured: 1 year
Duration of DAPT
To evaluate the difference in rate of ischemic events and all-cause mortality in patients with chronic thrombocytopenia maintained on DAPT with clopidogrel compared to patients maintained on DAPT with ticagrelor.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2024
- Study start22 Aug 2022
- Primary completion28 Dec 2026 (estimated)
- Study completion22 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Baseline ThrombocytopeniaStudies 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Methodist Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jessica Rago Crotty, Pharm D, Principal investigator, Methodist Midlothian Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06223607
- Sponsor's protocol ID
- 036.PHA.2022.D
- Status last verified
- Jan 2026
- First submitted
- 13 Nov 2023
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dual Antiplatelet Therapy (DAPT) in Patients With Baseline Thrombocytopenia
- ClinicalTrials.gov ID
- NCT06223607
- Acronym / sponsor ID
- 036.PHA.2022.D
- Conditions
- Baseline Thrombocytopenia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Methodist Health SystemUniversity, hospital or other
- Study start
- 22 Aug 2022 (actual)
- Primary completion
- 28 Dec 2026 (estimated)
- Study completion
- 22 Dec 2027 (estimated)
- First posted
- 25 Jan 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.
The use of clopidogrel as part of DAPT will be associated with lower bleeding rates compared to ticagrelor in patients with chronic thrombocytopenia requiring Percutaneous intervention (PCI )with Drug Eluting Stent (DES) or Bare Metal Stint(BMS).
Detailed description
Patients with thrombocytopenia are at an increased risk of both bleeding and ischemic events following PCI; however, there is a paucity of data on how to optimally manage these risks. Data indicates that ticagrelor is associated with reduced ischemic outcomes with an accompanying increased risk of bleed in the broader population. This study will assess P2Y12 agent selection in patients with chronic thrombocytopenia to determine if one better balances risks of ischemic and bleeding events following coronary intervention
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study population of 18 years of age ,PCI with either DES or BMS during study time period (April 1, 2018 through July 1 2021) ,Thrombocytopenia on at least one occasion prior to PCI and at least one dose of DAPT post-PCI with aspirin and either clopidogrel or ticagrelor
Key inclusion criteria (4 listed)
- ≥ 18 years
- PCI with either DES or BMS during study time period (April 1, 2018 through July 1 2021)
- Thrombocytopenia defined as platelet count <100 x103 /µL on at least one occasion prior to PCI
- At least one dose of DAPT post-PCI with aspirin and either clopidogrel or ticagrelor
Key exclusion criteria (2 listed)
- Death within 48 hours post-PCI
- DAPT prior to cardiac catheterization
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
Incidence of bleeding
Time frame: 1 year
To evaluate the difference in bleeding rates in patients with chronic thrombocytopenia maintained on DAPT with clopidogrel compared to patients maintained on DAPT with ticagrelor.
3 secondary outcomes
Incidence of ischemic events
Time frame: 1 year
All-cause mortality
Time frame: 1 year
Duration of DAPT
Time frame: 1 year
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 10 Jun 2026.
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.
Jessica Rago Crotty, Pharm D principal investigator
Methodist Midlothian Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Baseline Thrombocytopenia, run by Methodist Health System at 1 site in United States.
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 4 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 10 Jun 2026. 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 United States. 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 Bethany Brauer (214-947-4681 ext. 74681, mhsirb@mhd.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of bleeding (time frame: 1 year). 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 10 Jun 2026.