InflammationPhase 4NCT02639143
Rapid P2Y12 Receptor Inhibition Attenuates Inflammatory Cell Infiltration in Thrombus Aspirated From the STEMI Patients
A Phase 4 study testing ticagrelor and Clopidogrel in people with Inflammation and Thrombosis, run by First Affiliated Hospital of Harbin Medical University.
Trial summary
This is a prospective, randomized, parallel design study to investigate that ticagrelor could attenuate inflammatory cell infiltration in thrombus aspirated from ST elevation myocardial infarction (STEMI) patients. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Inflammation, Thrombosis
- What is being tested?
- ticagrelor and Clopidogrel
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Dec 2015to Dec 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 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of informed consent prior to any study specific procedures
- Males and non-pregnant females > 18 and < 79 years of age.
- Symptoms consistent with STEMI lasting > 30 min.
- Arrival at the hospital within 12 h of the onset of chest pain.
- Intention to perform PCI
Who cannot join
- On treatment with a P2Y12 receptor antagonist (ticlopidine, clopidogrel, prasugrel, ticagrelor) in past 30 days.
- Known allergies to aspirin or ticagrelor or clopidogrel.
- On treatment with oral anticoagulant (Vitamin K antagonists, dabigatran, rivaroxaban).
- Treatment with IIb/IIIa glycoprotein inhibitors in the last 7 days.
- Known pregnancy, breast-feeding, or intend to become pregnant during the study period.
- Active pathological bleeding
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- History of prior intracranial bleeding.
- Renal dysfunction (serum creatinine levels ≥ 2.0 mg/dL).
- Severe, non-catheter-related coronary artery spasm.
- New York Heart Association (NYHA) class III or IV heart failure or known left ventricular ejection fraction < 30%.
- Known severe hepatic dysfunction.
- Hemodynamic or electrical instability (including shock).
- Concomitant inflammatory diseases, malignant tumours, anaemia or thrombocytopenia.
About this study
Official title: Rapid P2Y12 Receptor Inhibition Attenuates Inflammatory Cell Infiltration in Thrombus Aspirated From the Infarct-related Artery in STEMI Patients: A Prospective Randomized Trial of Ticagrelor Versus Clopidogrel
This is a prospective, randomized, parallel design study to investigate that ticagrelor could attenuate inflammatory cell infiltration in thrombus aspirated from ST elevation myocardial infarction (STEMI) patients. The anticipated duration of the study is approximately 9 months, including an anticipated enrolment period of 8 months and follow-up period of 1 month. Patients within 12 hours of symptom onset were randomly assigned in a one-to-one ratio to receive ticagrelor or clopidogrel at time of STEMI diagnosis. The primary endpoint was the extent of inflammatory cell infiltration in thrombus aspirated from STEMI patients, expressed as number of total inflammatory cells per mm2 thrombus area.
Read the detailed description
This is a prospective, randomized, parallel design study to investigate that ticagrelor could attenuate inflammatory cell infiltration in thrombus aspirated from STEMI patients. The anticipated duration of the study is approximately 9 months, including an anticipated enrolment period of 8 months and follow-up period of 1 month. Patients within 12 hours of symptom onset were randomly assigned in a one-to-one ratio to receive ticagrelor or clopidogrel at time of STEMI diagnosis. The primary endpoint was the extent of inflammatory cell infiltration in thrombus aspirated from STEMI patients, expressed as number of total inflammatory cells per mm2 thrombus area.
Screening will be made to select eligible participants before intervention. Patients with documented STEMI and within 12 hours of symptom onset will be enrolled from the study site. For patients post percutaneous coronary intervention (PCI), they must be on dual-antiplatelet therapy for at least 12 months to be eligible for the study.
After the enrollment period, patients were randomly assigned in a one-to-one ratio to receive ticagrelor (180 mg loading dose) or clopidogrel (600 mg loading dose) at time of STEMI diagnosis. In addition to randomized study medication all patients should receive concomitant Ace Salicylic Acid (ASA) 100 mg daily during the treatment period according to local practice, unless they are allergic or intolerant. For those not previously given aspirin, a loading dose of 300 mg was preferred. At the end of the study, data will be collected and analyzed.
- Conditions
- Inflammation, Thrombosis
- Being tested
- ticagrelor, Clopidogrel
- Medical subject headings
- Inflammation, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ticagrelorDrug
ClopidogrelDrug
| Study group | Role | What they receive |
|---|---|---|
| ticagrelor | Experimental | Ticagrelor, 180 mg, oral administration. followed by 90 mg bid Receives: Drug: ticagrelor |
| Clopidogrel | Active comparator | Clopidogrel 600 mg loading dose taken orally, followed by 75 mg qd. Receives: Drug: Clopidogrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of total inflammatory cells per mm2 thrombus area.
To evaluate the efficacy of ticagrelor compared to clopidogrel for the attenuation of inflammatory cell infiltration in thrombus aspirated from STEMI patients.
Measured: Thrombus will be got from aspiration in culprit lesions during primary PCI.It will be fixed immediately and tested in 48 hours.
Secondary outcomes (7)
Intracoronary thrombus size
Measured: Thrombus will be got from aspiration in culprit lesions during primary PCI.It will be fixed immediately and tested in 48 hours.
Number of neutrophils per mm2 thrombus area
Measured: Thrombus will be got from aspiration in culprit lesions during primary PCI.It will be fixed immediately and tested in 48 hours.
Number of macrophages per mm2 thrombus area
Measured: Thrombus will be got from aspiration in culprit lesions during primary PCI.It will be fixed immediately and tested in 48 hours.
Number of Myeloperoxidase-positive cells per mm2 thrombus area
Measured: Thrombus will be got from aspiration in culprit lesions during primary PCI.It will be fixed immediately and tested in 48 hours.
Serum high-sensitivity C-reactive protein level
A total of three times
Measured: after randomization and before loading dose P2Y12 receptor inhibitor,5-7 days after PCI,1 month ± 5 days.
Plasma concentration of ticagrelor
Measured: At 90 min, 2h, 8h, 12h and 24h after received loading dose P2Y12 receptor inhibitor.
Rate of Thrombolysis In Myocardial Infarction (TIMI) major bleeding
Measured: Follow up: 1 month ± 5 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2015 (estimated)
- Study startDec 2015
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InflammationStudies 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Harbin Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02639143
- Sponsor's protocol ID
- ESR-14-10167
- Status last verified
- Nov 2015
- First submitted
- 23 Nov 2015
- Last updated
- 23 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rapid P2Y12 Receptor Inhibition Attenuates Inflammatory Cell Infiltration in Thrombus Aspirated From the Infarct-related Artery in STEMI Patients: A Prospective Randomized Trial of Ticagrelor Versus Clopidogrel
- ClinicalTrials.gov ID
- NCT02639143
- Acronym / sponsor ID
- ESR-14-10167
- Conditions
- Inflammation, Thrombosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- First Affiliated Hospital of Harbin Medical UniversityUniversity, hospital or other
- Study start
- Dec 2015 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 24 Dec 2015 (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 is a prospective, randomized, parallel design study to investigate that ticagrelor could attenuate inflammatory cell infiltration in thrombus aspirated from ST elevation myocardial infarction (STEMI) patients. The anticipated duration of the study is approximately 9 months, including an anticipated enrolment period of 8 months and follow-up period of 1 month. Patients within 12 hours of symptom onset were randomly assigned in a one-to-one ratio to receive ticagrelor or clopidogrel at time of STEMI diagnosis. The primary endpoint was the extent of inflammatory cell infiltration in thrombus aspirated from STEMI patients, expressed as number of total inflammatory cells per mm2 thrombus area.
Detailed description
This is a prospective, randomized, parallel design study to investigate that ticagrelor could attenuate inflammatory cell infiltration in thrombus aspirated from STEMI patients. The anticipated duration of the study is approximately 9 months, including an anticipated enrolment period of 8 months and follow-up period of 1 month. Patients within 12 hours of symptom onset were randomly assigned in a one-to-one ratio to receive ticagrelor or clopidogrel at time of STEMI diagnosis. The primary endpoint was the extent of inflammatory cell infiltration in thrombus aspirated from STEMI patients, expressed as number of total inflammatory cells per mm2 thrombus area.
Screening will be made to select eligible participants before intervention. Patients with documented STEMI and within 12 hours of symptom onset will be enrolled from the study site. For patients post percutaneous coronary intervention (PCI), they must be on dual-antiplatelet therapy for at least 12 months to be eligible for the study.
After the enrollment period, patients were randomly assigned in a one-to-one ratio to receive ticagrelor (180 mg loading dose) or clopidogrel (600 mg loading dose) at time of STEMI diagnosis. In addition to randomized study medication all patients should receive concomitant Ace Salicylic Acid (ASA) 100 mg daily during the treatment period according to local practice, unless they are allergic or intolerant. For those not previously given aspirin, a loading dose of 300 mg was preferred. At the end of the study, data will be collected and analyzed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ticagrelor | Experimental | Drug: ticagrelorTicagrelor, 180 mg, oral administration. followed by 90 mg bid |
| Clopidogrel | Active comparator | Drug: ClopidogrelClopidogrel 600 mg loading dose taken orally, followed by 75 mg qd. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Provision of informed consent prior to any study specific procedures
- Males and non-pregnant females > 18 and < 79 years of age.
- Symptoms consistent with STEMI lasting > 30 min.
- Arrival at the hospital within 12 h of the onset of chest pain.
- Intention to perform PCI
Key exclusion criteria (13 listed)
- On treatment with a P2Y12 receptor antagonist (ticlopidine, clopidogrel, prasugrel, ticagrelor) in past 30 days.
- Known allergies to aspirin or ticagrelor or clopidogrel.
- On treatment with oral anticoagulant (Vitamin K antagonists, dabigatran, rivaroxaban).
- Treatment with IIb/IIIa glycoprotein inhibitors in the last 7 days.
- Known pregnancy, breast-feeding, or intend to become pregnant during the study period.
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 | ticagrelor |
| Clopidogrel | Drug | Clopidogrel |
Primary outcome
Number of total inflammatory cells per mm2 thrombus area.
Time frame: Thrombus will be got from aspiration in culprit lesions during primary PCI.It will be fixed immediately and tested in 48 hours.
To evaluate the efficacy of ticagrelor compared to clopidogrel for the attenuation of inflammatory cell infiltration in thrombus aspirated from STEMI patients.
7 secondary outcomes
Intracoronary thrombus size
Time frame: Thrombus will be got from aspiration in culprit lesions during primary PCI.It will be fixed immediately and tested in 48 hours.
Number of neutrophils per mm2 thrombus area
Time frame: Thrombus will be got from aspiration in culprit lesions during primary PCI.It will be fixed immediately and tested in 48 hours.
Number of macrophages per mm2 thrombus area
Time frame: Thrombus will be got from aspiration in culprit lesions during primary PCI.It will be fixed immediately and tested in 48 hours.
Number of Myeloperoxidase-positive cells per mm2 thrombus area
Time frame: Thrombus will be got from aspiration in culprit lesions during primary PCI.It will be fixed immediately and tested in 48 hours.
Serum high-sensitivity C-reactive protein level
Time frame: after randomization and before loading dose P2Y12 receptor inhibitor,5-7 days after PCI,1 month ± 5 days.
Plasma concentration of ticagrelor
Time frame: At 90 min, 2h, 8h, 12h and 24h after received loading dose P2Y12 receptor inhibitor.
Rate of Thrombolysis In Myocardial Infarction (TIMI) major bleeding
Time frame: Follow up: 1 month ± 5 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 23 Aug 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ticagrelor and Clopidogrel in people with Inflammation and Thrombosis, run by First Affiliated Hospital of Harbin Medical University.
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 13 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 23 Aug 2021. 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.
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?
Number of total inflammatory cells per mm2 thrombus area. (time frame: Thrombus will be got from aspiration in culprit lesions during primary PCI.It will be fixed immediately and tested in 48 hours.). 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 Aug 2021.