Coronary Heart DiseasePhase 4NCT03006835
Different Dosage of Domestic and Imported Clopidogrel on the Platelet Inhibition Ratio in Patients Undergoing PCI
A Phase 4 study testing Clopidogrel in people with Coronary Heart Disease, run by Xijing Hospital.
Trial summary
This is a single-center, randomized, single-blind, investigator-initiated, pharmacological study with a parallel design. Patients with non-ACS undergoing primary percutaneous coronary intervention will be randomized after informed consent, in a 1:1:1:1 ratio to the following treatment groups: Group Α: Domestic… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Coronary Heart Disease
- What is being tested?
- Clopidogrel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient is scheduled to undergo non-urgent PCI
- The patient is between 18 and 75 years of age (inclusive) and willing to comply with the protocol
- The patient or legally acceptable representative is able to read and give written informed consent and has signed an informed consent form approved by the Investigator's IRB/IEC
Who cannot join
- Estimated or measured weight < 55 kg
- Acute non-ST-segment elevation myocardial infarction (NSTEMI) or ST-segment elevation myocardial infarction (STEMI) within 7 days prior to PCI
- Uncontrolled hypertension at the time of initial study drug administration defined as measured systolic blood pressure > 190 mm Hg or diastolic blood pressure > 108 mm Hg
- Patient has received a clopidogrel loading dose (≥300 mg) within 30 days prior to randomization; patients on maintenance clopidogrel may be enrolled
- Administration of thrombolytic agents, fondaparinux, or oral anticoagulants (e.g., warfarin) within the 7 days prior to PCI
- Estimated creatinine clearance (e.g. Cockcroft-Gault) < 45 mL/min
Show all 15Show fewer
- Anemia with hemoglobin level < 10 g/dL
- Thrombocytopenia (platelet count < 100,000/mm3)
- ALT and/or AST > 2.5 x the ULN or other indication of clinically significant hepatic dysfunction
- Facial or head trauma within the last 30 days
- Intraocular hemorrhage within the last 30 days
- Gastrointestinal bleeding within the last 30 days
- Active bleeding, or history of a bleeding disorder or known intracranial vascular malformation
- Known allergy or contraindication to aspirin, heparin, clopidogrel, or to any contrast media
- Participation in any investigational drug study within 30 days prior to enrollment.
Trial locations and contacts
No sites are listed yet.
About this study
This is a single-center, randomized, single-blind, investigator-initiated, pharmacological study with a parallel design. Patients with non-ACS undergoing primary percutaneous coronary intervention will be randomized after informed consent, in a 1:1:1:1 ratio to the following treatment groups:
Group Α: Domestic Clopidogrel 300mg as a loading dose before PCI, followed by 75mg per day.
Read more
Group B: Domestic Clopidogrel 600mg as a loading dose before PCI, followed by 75mg per day.
Group B: Imported Clopidogrel 300mg as a loading dose before PCI, followed by 75mg per day.
Group D: Imported Clopidogrel 600mg as a loading dose before PCI, followed by 75mg per day.
Platelet inhibition ratio assessment by thrombelastogram will be performed，2 hours after the loading dose(Day 0)， 6 hours after thrombelastogram (Day 0), 30 day after thrombelastogram. Documentation of major adverse cardiac events (death, myocardial infarction, stroke, revascularization procedure with PCI or CABG) and serious adverse events (bleeding, other adverse events)will be performed until Day 30.
- Conditions
- Coronary Heart Disease
- Being tested
- Clopidogrel
- Keywords
- Clopidogrel; Platelet Inhibition Ratio
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClopidogrelDrug
| Study group | Role | What they receive |
|---|---|---|
| Domestic Clopidogrel 300mg | Experimental | Domestic Clopidogrel 300mg Receives: Drug: Clopidogrel |
| Domestic Clopidogrel 600mg | Experimental | Domestic Clopidogrel 600mg Receives: Drug: Clopidogrel |
| Imported Clopidogrel 300mg | Experimental | Imported Clopidogrel 300mg Receives: Drug: Clopidogrel |
| Imported Clopidogrel 600mg | Active comparator | Imported Clopidogrel 600mg Receives: Drug: Clopidogrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
ADP- induced platelet inhibition rate
Measured: 2 hours after the loading dose
ADP- induced platelet inhibition rate
Measured: 6 hours after the loading dose
ADP- induced platelet inhibition rate
Measured: 30 days after the loading dose
Secondary outcomes (1)
R value (min)
Measured: 2 hours after the loading dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2016 (estimated)
- Study startJan 2017
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shenzhen Salubris Pharmaceuticals Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- ruining zhang, doctor, Study director, Xijing Hospital, The Fourth Military Medical University, 15 Changle West Road, Xi'an, 710032, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03006835
- Sponsor's protocol ID
- ky20162060-2
- Status last verified
- Dec 2016
- First submitted
- 27 Dec 2016
- Last updated
- 30 Dec 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Different Dosage of Domestic and Imported Clopidogrel on the Platelet Inhibition Ratio in Patients Undergoing PCI
- ClinicalTrials.gov ID
- NCT03006835
- Acronym / sponsor ID
- ky20162060-2
- Conditions
- Coronary Heart Disease
- Keywords
- Clopidogrel; Platelet Inhibition Ratio
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Collaborators
- Shenzhen Salubris Pharmaceuticals Co., Ltd.
- Study start
- Jan 2017
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 30 Dec 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.
This is a single-center, randomized, single-blind, investigator-initiated, pharmacological study with a parallel design. Patients with non-ACS undergoing primary percutaneous coronary intervention will be randomized after informed consent, in a 1:1:1:1 ratio to the following treatment groups:
Group Α: Domestic Clopidogrel 300mg as a loading dose before PCI, followed by 75mg per day.
Group B: Domestic Clopidogrel 600mg as a loading dose before PCI, followed by 75mg per day.
Group B: Imported Clopidogrel 300mg as a loading dose before PCI, followed by 75mg per day.
Group D: Imported Clopidogrel 600mg as a loading dose before PCI, followed by 75mg per day.
Platelet inhibition ratio assessment by thrombelastogram will be performed，2 hours after the loading dose(Day 0)， 6 hours after thrombelastogram (Day 0), 30 day after thrombelastogram. Documentation of major adverse cardiac events (death, myocardial infarction, stroke, revascularization procedure with PCI or CABG) and serious adverse events (bleeding, other adverse events)will be performed until Day 30.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Domestic Clopidogrel 300mg | Experimental | Drug: ClopidogrelDomestic Clopidogrel 300mg |
| Domestic Clopidogrel 600mg | Experimental | Drug: ClopidogrelDomestic Clopidogrel 600mg |
| Imported Clopidogrel 300mg | Experimental | Drug: ClopidogrelImported Clopidogrel 300mg |
| Imported Clopidogrel 600mg | Active comparator | Drug: ClopidogrelImported Clopidogrel 600mg |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The patient is scheduled to undergo non-urgent PCI
- The patient is between 18 and 75 years of age (inclusive) and willing to comply with the protocol
- The patient or legally acceptable representative is able to read and give written informed consent and has signed an informed consent form approved by the Investigator's IRB/IEC
Key exclusion criteria (15 listed)
- Estimated or measured weight < 55 kg
- Acute non-ST-segment elevation myocardial infarction (NSTEMI) or ST-segment elevation myocardial infarction (STEMI) within 7 days prior to PCI
- Uncontrolled hypertension at the time of initial study drug administration defined as measured systolic blood pressure > 190 mm Hg or diastolic blood pressure > 108 mm Hg
- Patient has received a clopidogrel loading dose (≥300 mg) within 30 days prior to randomization; patients on maintenance clopidogrel may be enrolled
- Administration of thrombolytic agents, fondaparinux, or oral anticoagulants (e.g., warfarin) within the 7 days prior to PCI
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 |
|---|---|---|
| Clopidogrel | Drug | Domestic Clopidogrel 300mg, Domestic Clopidogrel 600mg, Imported Clopidogrel 300mg, Imported Clopidogrel 600mg |
Primary outcome
ADP- induced platelet inhibition rate
Time frame: 2 hours after the loading dose
ADP- induced platelet inhibition rate
Time frame: 6 hours after the loading dose
ADP- induced platelet inhibition rate
Time frame: 30 days after the loading dose
1 secondary outcome
R value (min)
Time frame: 2 hours after the loading dose
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2016.
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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.
ruining zhang, doctor study director
Xijing Hospital, The Fourth Military Medical University, 15 Changle West Road, Xi'an, 710032, China
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Clopidogrel in people with Coronary Heart Disease, run by Xijing Hospital.
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 15 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: status not confirmed, as of the sponsor's last update on 30 Dec 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact yi liu, doctor (86-029-84775183, 1391643423@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ADP- induced platelet inhibition rate (time frame: 2 hours after the loading dose). The study lists 3 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 30 Dec 2016.