Coronary Artery DiseasePhase 2NCT03599284
The Efficacy, Safety and Pharmacokinetic of Antiplatelet Therapy for Vicagrel
A Phase 2 study testing Vicagrel 5mg, Vicagrel 6mg and Vicagrel 7.5mg in people with Coronary Artery Disease and Percutaneous Coronary Intervention, run by Jiangsu vcare pharmaceutical technology co., LTD at 27 sites in China.
Trial summary
This is a multi-center, randomized, double-blind, triple-dummy, parallel-controled, dose-exploration phase II trial. Patients with coronary atherosclerotic heart disease and planned percutaneous coronary intervention （PCI） will be randomized after informed consent, in a 1:1:1:1 ratio to the following treatment groups… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Coronary Artery Disease, Percutaneous Coronary Intervention, Platelet Aggregation Inhibitors
- What is being tested?
- Vicagrel 5mg, Vicagrel 6mg and Vicagrel 7.5mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 279 participants
- Where
- 27 sitesChina
- Study dates
- 30 Aug 2018to 28 Jul 2019
- Phase
- Phase 2
- 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
- Male and female aged 18-75.
- Weight ≥ 50 kg
- Patients with coronary atherosclerotic heart disease diagnosed clinically and planned percutaneous coronary intervention
- Patients with ability and willingness to sign informed consent and adherence to trial protocol.
Who cannot join
- Hemorrhagic symptoms (such as hematemesis, melena, severe or recurrent epistaxis, hemoptysis, marked hematuria, gastrointestinal bleeding, or intracranial hemorrhage), or suspected vascular malformations (such as aneurysms), or abnormal bleeding history (such as abnormal hemorrhage attributed to tooth extraction), himself or his immediate family with coagulation or bleeding disorders (such as hemophilia);
- Non-ST-segment elevation acute coronary syndrome (<2h emergency PCI), or ST-segment elevation myocardial infarction within 7 days;
- Patients with suspected aortic dissection;
- Patients with negative coronary Computed Tomography angiography（CTA）(coronary CTA depending on investigator);
- Patients with severe disease and life expectancy <1 year;
- Patients with acute peptic ulcer;
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- History of hemorrhagic stroke or history of ischemic stroke within 6 months before screening and a definite diagnosis of structural abnormalities in the central nervous system;
- Patients with uncontrolled high blood pressure (systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 110 mmHg) after drug treatment during screening;
- One of the following conditions: cardiogenic shock, chronic congestive heart with failure New York Heart Association (NYHA) grade ≥ III grade or left ventricular ejection fraction determined by echocardiography < 35%, hypotension (systolic pressure < 90 mmHg and or diastolic pressure < 60 mmHg), severe arrhythmias (including high-degree atrioventricular block, sick sinus syndrome, persistent ventricular tachycardia), severe pulmonary insufficiency, pulmonary embolism, and hepatic insufficiency (ALT or AST caused by non-cardiac diseases exceeding the upper limit of normal by more than 3 times), severe renal insufficiency (eGFR < 30 ml/min), cirrhosis;
- Patients Received P2Y12 receptor antagonist and Ⅱb/IIIa receptor inhibitor, oral anticoagulant (warfarin, rivaroxaban, dabigatran, etc.) within 14 days before screening;
- Prolonged cardiopulmonary resuscitation (more than 10 minutes) or severe trauma within 2 weeks before screening;
- Patients plan to undergo another surgery within 1 month after participating in this trial，or plan to undergo PCI procedure performed several times during the test (except for the end of the safety follow-up);
- History of severe allergies, non-allergic drug reactions or allergies to 2 or more drugs (including contrast agents), or known allergies to the similar drugs (clopidogrel, ticagrelor) as the study drug or contraindication of aspirin;
- Patients with mental disorders or alcohol dependence;
- Patients being receiving any experimental medicine or experimental medical devices;
- Prothrombin time (PT)> 1.3 times the upper limit of normal or international normalized ratio (INR)> 2.0;
- Platelet count (PLT) < 100×10^9/L or > 600×10^9/L;
- Hemoglobin < 10g/dL;
- Patients who cannot tolerate dual antiplatelet therapy for 28 days;
- Female of reproductive age with positive blood pregnancy test;
- Female with gestational intention or in lactation;
- Other unsuitable conditions considered by investigators.
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
China27 sites
Beijing Anzhen Hospital, Capital Medical Universily
Beijing, Beijing Municipality, 100029
China-Japan Friendship Hospital
Beijing, 100029
Peking Union Medical College Hospital
Beijing, 100032
First Affiliated Hospital Bengbu Medical College
Bengbu, Anhui, 233004
First Hospital of Jilin University
Changchun, Jilin, 130021
Second Hospital of Jilin University
Changchun, Jinin, 130041
Changsha Central Hospital
Changsha, Hunan, 410004
Xiangya Hospital of Central South University
Changsha, Hunan, 410008
Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011
Third Xiangya Hospital of Central South University
Changsha, Hunan, 410013
Guangdong General Hospital
Guangzhou, Guangdong, 510030
First Affiliated Hospital of Zhongshan University
Guangzhou, Guangdong, 510080
Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
Sir Run Run Shaw Hospital
Hangzhou, Zhejiang, 310020
Affiliated Hospital of Southwest Medical University
Luzhou, Sichuan, 646000
Jiangxi Provincial People's Hospital
Nanchang, Jiangxi, 330006
Affiliated Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, 210008
Zhongda Hospital of Southeast University
Nanjing, Jiangsu, 210009
the General Hospital of Shenyang Military Region of The Chinese People's Liberation Army（The General Hospital of Shenyang Military）
Shenyang, Liaoning, 110015
The People's Hospital of Liaoning Province
Shenyang, Liaoning, 110015
Shengjing Hospital of China Medical University
Shenyang, Liaoning, 110134
First Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050100
Tianjin People's Hospital
Tianjin, 300121
Tianjin Medical University General Hospital
Tianjing, 300052
Wuhan Asia Heart Hospital
Wuhan, Hubei, 430022
Qinghai Provincial People's Hospital
Xining, Qinghai, 810007
Yuncheng Central Hospital
Yuncheng, Shanxi, 044000
About this study
Official title: The Efficacy, Safety and Pharmacokinetic of Antiplatelet Therapy for Vicagrel in Patients With Coronary Atherosclerotic Heart Disease and Planned Percutaneous Coronary Intervention: a Multi-center, Randomized, Double-blind, Triple-dummy , Parallel-controlled, Dose-exploration Phase II Trial
This is a multi-center, randomized, double-blind, triple-dummy, parallel-controled, dose-exploration phase II trial. Patients with coronary atherosclerotic heart disease and planned percutaneous coronary intervention （PCI） will be randomized after informed consent, in a 1:1:1:1 ratio to the following treatment groups: Experimental group 1 : Vicagrel 20mg loading followed by 5mg/day for 28 days; Experimental group 2 : Vicagrel 24mg loading followed by 6mg/day for 28 days; Experimental group 3 : Vicagrel 30mg loading followed by 7.5mg/day for 28 days; Control group : Clopidogrel 300mg loading followed by 75mg/day for 28 days. The primary purpose of this trial is to evaluate the efficacy, safety of vicagrel antiplatelet therapy and explore dose in patients with coronary atherosclerotic heart disease during and after PCI compared with clopidogrel.
- Conditions
- Coronary Artery Disease, Percutaneous Coronary Intervention, Platelet Aggregation Inhibitors
- Being tested
- Vicagrel 5mg, Vicagrel 6mg, Vicagrel 7.5mg, Clopidogrel 75mg
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vicagrel 5mgDrug
Experimental group 1 : Vicagrel 20mg loading followed by 5mg/day for 28 days
Vicagrel 6mgDrug
Experimental group 2 : Vicagrel 24mg loading followed by 6mg/day for 28 days
Vicagrel 7.5mgDrug
Experimental group 3 : Vicagrel 30mg loading followed by 7.5mg/day for 28 days
Clopidogrel 75mgDrug
Control group : Clopidogrel 300mg loading followed by 75mg/day for 28 days
| Study group | Role | What they receive |
|---|---|---|
| Experimental group 1 | Experimental | Experimental group 1: Vicagrel 20mg loading followed by 5mg/day for 28 days Receives: Drug: Vicagrel 5mg |
| Experimental group 2 | Experimental | Experimental group 2: Vicagrel 24mg loading followed by 6mg/day for 28 days Receives: Drug: Vicagrel 6mg |
| Experimental group 3 | Experimental | Experimental group 3: Vicagrel 30mg loading followed by 7.5mg/day for 28 days Receives: Drug: Vicagrel 7.5mg |
| Control group | Active comparator | Control group: Clopidogrel 300mg loading followed by 75mg/day for 28 days Receives: Drug: Clopidogrel 75mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inhibition of platelet aggregation
Inhibition of platelet aggregation will be assessed by Verifynow System
Measured: 28 days after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start30 Aug 2018
- Primary completion11 Jun 2019
- Study completion28 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Jiangsu vcare pharmaceutical technology co., LTDThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 279 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu vcare pharmaceutical technology co., LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03599284
- Sponsor's protocol ID
- VCP1-Ⅱ-01
- Status last verified
- Jul 2018
- First submitted
- 9 Jul 2018
- Last updated
- 23 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy, Safety and Pharmacokinetic of Antiplatelet Therapy for Vicagrel in Patients With Coronary Atherosclerotic Heart Disease and Planned Percutaneous Coronary Intervention: a Multi-center, Randomized, Double-blind, Triple-dummy , Parallel-controlled, Dose-exploration Phase II Trial
- ClinicalTrials.gov ID
- NCT03599284
- Acronym / sponsor ID
- VCP1-Ⅱ-01
- Conditions
- Coronary Artery Disease, Percutaneous Coronary Intervention, Platelet Aggregation Inhibitors
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 279 participants (actual)
- Lead sponsor
- Jiangsu vcare pharmaceutical technology co., LTDIndustry (pharma, biotech, devices)
- Study start
- 30 Aug 2018 (actual)
- Primary completion
- 11 Jun 2019 (actual)
- Study completion
- 28 Jul 2019 (actual)
- First posted
- 26 Jul 2018 (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 is a multi-center, randomized, double-blind, triple-dummy, parallel-controled, dose-exploration phase II trial. Patients with coronary atherosclerotic heart disease and planned percutaneous coronary intervention （PCI） will be randomized after informed consent, in a 1:1:1:1 ratio to the following treatment groups: Experimental group 1 : Vicagrel 20mg loading followed by 5mg/day for 28 days; Experimental group 2 : Vicagrel 24mg loading followed by 6mg/day for 28 days; Experimental group 3 : Vicagrel 30mg loading followed by 7.5mg/day for 28 days; Control group : Clopidogrel 300mg loading followed by 75mg/day for 28 days. The primary purpose of this trial is to evaluate the efficacy, safety of vicagrel antiplatelet therapy and explore dose in patients with coronary atherosclerotic heart disease during and after PCI compared with clopidogrel.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Experimental group 1 | Experimental | Drug: Vicagrel 5mgExperimental group 1: Vicagrel 20mg loading followed by 5mg/day for 28 days |
| Experimental group 2 | Experimental | Drug: Vicagrel 6mgExperimental group 2: Vicagrel 24mg loading followed by 6mg/day for 28 days |
| Experimental group 3 | Experimental | Drug: Vicagrel 7.5mgExperimental group 3: Vicagrel 30mg loading followed by 7.5mg/day for 28 days |
| Control group | Active comparator | Drug: Clopidogrel 75mgControl group: Clopidogrel 300mg loading followed by 75mg/day for 28 days |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male and female aged 18-75.
- Weight ≥ 50 kg
- Patients with coronary atherosclerotic heart disease diagnosed clinically and planned percutaneous coronary intervention
- Patients with ability and willingness to sign informed consent and adherence to trial protocol.
Key exclusion criteria (22 listed)
- Hemorrhagic symptoms (such as hematemesis, melena, severe or recurrent epistaxis, hemoptysis, marked hematuria, gastrointestinal bleeding, or intracranial hemorrhage), or suspected vascular malformations (such as aneurysms), or abnormal bleeding history (such as abnormal hemorrhage attributed to tooth extraction), himself or his immediate family with coagulation or bleeding disorders (such as hemophilia);
- Non-ST-segment elevation acute coronary syndrome (<2h emergency PCI), or ST-segment elevation myocardial infarction within 7 days;
- Patients with suspected aortic dissection;
- Patients with negative coronary Computed Tomography angiography（CTA）(coronary CTA depending on investigator);
- Patients with severe disease and life expectancy <1 year;
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 |
|---|---|---|
| Vicagrel 5mgExperimental group 1 : Vicagrel 20mg loading followed by 5mg/day for 28 days | Drug | Experimental group 1 |
| Vicagrel 6mgExperimental group 2 : Vicagrel 24mg loading followed by 6mg/day for 28 days | Drug | Experimental group 2 |
| Vicagrel 7.5mgExperimental group 3 : Vicagrel 30mg loading followed by 7.5mg/day for 28 days | Drug | Experimental group 3 |
| Clopidogrel 75mgControl group : Clopidogrel 300mg loading followed by 75mg/day for 28 days | Drug | Control group |
Primary outcome
Inhibition of platelet aggregation
Time frame: 28 days after treatment
Inhibition of platelet aggregation will be assessed by Verifynow System
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 Sep 2019.
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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.
27 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vicagrel 5mg, Vicagrel 6mg and Vicagrel 7.5mg in people with Coronary Artery Disease and Percutaneous Coronary Intervention, run by Jiangsu vcare pharmaceutical technology co., LTD at 27 sites 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 4 inclusion and 22 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 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Inhibition of platelet aggregation (time frame: 28 days after treatment). 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 Sep 2019.