Coronary Artery DiseasePhase 1DPABIAPNCT03078257
Different Platelet Activities Between Intracoronary and Peripheral Blood in Coronary Artery Disease Patients
A Phase 1 study testing tirofiban in PV, tirofiban in IC and antiplatelet thrombolysin in people with Coronary Artery Disease, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
Antiplatelet treatment is important for coronary artery disease(CAD) patients .Some patients are resistant to antiplatelet treatment based on platelet function tests(PFT).Currently the results of PFT are mainly based on the analysis of peripheral blood. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- tirofiban in PV, tirofiban in IC and antiplatelet thrombolysin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2016to Dec 2017
- Phase
- Phase 1
- 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
- CAD patients plan to receive coronary arteriography (CAG) or percutaneous coronary intervention (PCI).
- Patient aged >18 years and ≦75 years old;
- Signed inform consent
Who cannot join
- Allergy or intolerance to ASA, clopidogrel , tirofiban ,antiplatelet thrombolysin;
- Subjects at a high risk of bleeding (e.g. platelet count< 100*109/L, known bleeding diathesis , active peptic ulcer );
- Patients who are planning to take warfarin or drugs that potentially could interfere with the anti-platelet effects .
- severe hemodynamic instability
- severe liver and renal dysfunction
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210029
Fuming Zhang, M.D., +86-25-83718836 ext. 6360, jsphkj@163.com
Yi Chai, M.D., +86-25-83718836 ext. 6360, jsphkj@163.com
About this study
Antiplatelet treatment is important for coronary artery disease(CAD) patients .Some patients are resistant to antiplatelet treatment based on platelet function tests(PFT).Currently the results of PFT are mainly based on the analysis of peripheral blood. instead, adverse cardiovascular events in CAD patients may be more directly related to platelet activities in the coronary arteries. There's no evidence of system study to prove the PFT of peripheral blood can represent the platelet functions in coronary arteries.The purpose of this study is to determine the different platelet activities in the blood of peripheral vein (PV), peripheral artery (PA), intracoronary artery (IC) in the CAD patients without or with different interventions.
our study is divided into three parts: Part A: To study the different platelet activities in the blood of PV, PA, IC in the CAD patients with dual antiplatelet therapy.
Read more
Part B: To explore the different platelet activities of the above three sites in ST-segment elevation myocardial infarction (STEMI) patients who are administrated platelet membrane glycoprotein Ⅱb/Ⅲa (GPⅡb/Ⅲa) receptor antagonist ( tirofiban ) in PV or IC and dual antiplatelet therapy.
Part C: To explore the different platelet activities of the above three sites in STEMI patients who are administrated antiplatelet thrombolysin or placebo in PV and dual antiplatelet therapy.
Read the detailed description
Part A:A total of 30 CAD patients are recruited.All patients are on loading dose of 300 mg clopidogrel followed by a maintenance dose of 75 mg/d for at least 5 days and a loading dose of 300 mg aspirin followed by a maintenance dose of 100 mg/d for at least 5 days. All patients plan to receive coronary arteriography (CAG) or percutaneous coronary intervention (PCI).The investigators sample blood from PV,PA and IC before PCI.Regional differences will be compared between blood samples from PV,PA and IC by light aggregometry (agonists: arachidonic acid, LTA-AA; adenosine diphosphat, LTA-ADP), VerifyNow P2Y12 assays. Differences between LTA and VerifyNow P2Y12-assay will also be compared.
Part B:A total of 30 STEMI patients are recruited.Patients are randomly assigned to 2 groups.A group(n=15) is given tirofiban through PV, the other group(n=15) is given through IC.All patients are on loading dose of 600 mg clopidogrel and 300 mg aspirin.All patients plan to receive emergency PCI. Group PV: a loading dose of 10ug/kg tirofiban is given in 3 min through PV,followed by a maintenance dose of 0.15ug/kg*min for 48h.Group IC: a loading dose of 10ug/kg tirofiban is given through IC,followed by a maintenance dose of 0.15ug/kg*min for 48h. Blood samples are collceted from PV, PA and IC before the injection of loading dose tirofiban , and 15min after the injection.Regional differences will be compared between blood samples from PV,PA and IC by LTA-AA; LTA-ADP, LTA-RIS(agonists:ristocetin),VerifyNow P2Y12 assays.
Part C:A total of 30 STEMI patients are recruited.Patients are randomly assigned to 2 groups.A group(n=15) is given antiplatelet thrombolysin(the frist antiplatelet drugs based on GP Ib receptor which completed the preclinical and phase I clinical studies,and already has entered phase II clinical studies) through PV, the other group(n=15) is given placebo through PV.All patients are on loading dose of 600 mg clopidogrel and 300 mg aspirin.All patients plan to receive emergency PCI.Both Groups are given in the same way , a loading dose of 5 IU/60kg in 5 min through PV,followed by a maintenance dose of 0.002 IU/kg/h for 48h. Blood samples are collceted from PV, PA and IC before the injection of loading dose of antiplatelet thrombolysin or placebo, and 15 min after the injection.Regional differences will be compared between blood samples from PV,PA and IC by LTA-AA; LTA-ADP, LTA-RIS and VerifyNow P2Y12 assays.
- Conditions
- Coronary Artery Disease
- Being tested
- tirofiban in PV, tirofiban in IC, antiplatelet thrombolysin, placebo, Clopidogrel
- Keywords
- Platelet Activities, light aggregometry, VerifyNow P2Y12-assay, peripheral vein, peripheral artery, intracoronary artery, tirofiban, antiplatelet thrombolysin
- 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.
tirofiban in PVDrug
Also called GPⅡb/Ⅲa receptor antagonist
a loading dose of 10ug/kg tirofiban is given in 3 min through PV,followed by a maintenance dose of 0.15ug/kg*min for 48h.
(clopidogrel 600 mg+aspirin( ASA) 300 mg)x1 day.
tirofiban in ICDrug
Also called GP IIb/IIIa receptor antagonist
a loading dose of 10ug/kg tirofiban is given in 3 min through IC,followed by a maintenance dose of 0.15ug/kg*min for 48h.
(clopidogrel 600 mg+ ASA 300 mg)x1 day.
antiplatelet thrombolysinDrug
Also called GP Ib receptor antagonist
a loading dose of 5 IU/60kg in 5 min through PV,followed by a maintenance dose of 0.002 IU/kg/h for 48h.
(clopidogrel 600 mg+ ASA 300 mg)x1 day.
placeboDrug
a loading dose of 5 IU/60kg in 5 min through PV,followed by a maintenance dose of 0.002 IU/kg/h for 48h.
(clopidogrel 600 mg+ ASA 300 mg)x1 day.
ClopidogrelDrug
loading dose of 300 mg clopidogrel followed by a maintenance dose of 75 mg/d for at least 5 days
AspirinDrug
loading dose of 300 mg aspirin followed by a maintenance dose of 100 mg/d for at least 5 days.
ClopidogrelDrug
loading dose of 600 mg clopidogrel followed by a maintenance dose of 75 mg/d for at least 5 days
| Study group | Role | What they receive |
|---|---|---|
| dual antiplatelet therapy | Experimental | clopidogrel +aspirin Receives: Drug: Clopidogrel; Drug: Aspirin |
| tirofiban in PV | Experimental | clopidogrel +aspirin + tirofiban in PV Receives: Drug: tirofiban in PV; Drug: Aspirin; Drug: Clopidogrel |
| tirofiban in IC | Experimental | clopidogrel +aspirin +tirofiban in IC Receives: Drug: tirofiban in IC; Drug: Aspirin; Drug: Clopidogrel |
| antiplatelet thrombolysin | Experimental | clopidogrel +aspirin +antiplatelet thrombolysin Receives: Drug: antiplatelet thrombolysin; Drug: Aspirin; Drug: Clopidogrel |
| placebo | Placebo comparator | clopidogrel +aspirin +placebo Receives: Drug: placebo; Drug: Aspirin; Drug: Clopidogrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
platelet aggregation
Regional differences between blood samples from PV,PA and IC by LTA and VerifyNow P2Y12 assays.The results of LTA are reported in platelet aggregation rate（%）.Platelet aggregation was induced using 0.5 mg/ml arachidonic acid (AA) and 5 μmol/l ADP.The maximum aggregation achieved during an 8-minute period was used for analysis.The results of the VerifyNow P2Y12-assay are reported in P2Y12 reaction units (PRU).(using 20 μmol/l ADP as the agonist and 22 nmol/l prostag- landin E1 (PGE1). a value that uses iso- thrombin receptor-activating peptide to approximate a baseline off-drug platelet reactivity value, and percentage inhibition.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2017
- Study start1 Jan 2016
- Primary completionNov 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 Artery DiseaseStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Natural Science Foundation of China
- Responsible party
- Principal investigator, Chunjian Li, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03078257
- Sponsor's protocol ID
- 005
- Acronym
- DPABIAP
- Status last verified
- Mar 2017
- First submitted
- 23 Feb 2017
- Last updated
- 13 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Different Platelet Activities Between Intracoronary and Peripheral Blood in Coronary Artery Disease Patients
- ClinicalTrials.gov ID
- NCT03078257
- Acronym / sponsor ID
- DPABIAP / 005
- Conditions
- Coronary Artery Disease
- Keywords
- Platelet Activities, light aggregometry, VerifyNow P2Y12-assay, peripheral vein, peripheral artery, intracoronary artery, tirofiban, antiplatelet thrombolysin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Collaborators
- National Natural Science Foundation of China
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- Nov 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 13 Mar 2017 (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.
Antiplatelet treatment is important for coronary artery disease(CAD) patients .Some patients are resistant to antiplatelet treatment based on platelet function tests(PFT).Currently the results of PFT are mainly based on the analysis of peripheral blood. instead, adverse cardiovascular events in CAD patients may be more directly related to platelet activities in the coronary arteries. There's no evidence of system study to prove the PFT of peripheral blood can represent the platelet functions in coronary arteries.The purpose of this study is to determine the different platelet activities in the blood of peripheral vein (PV), peripheral artery (PA), intracoronary artery (IC) in the CAD patients without or with different interventions.
our study is divided into three parts: Part A: To study the different platelet activities in the blood of PV, PA, IC in the CAD patients with dual antiplatelet therapy.
Part B: To explore the different platelet activities of the above three sites in ST-segment elevation myocardial infarction (STEMI) patients who are administrated platelet membrane glycoprotein Ⅱb/Ⅲa (GPⅡb/Ⅲa) receptor antagonist ( tirofiban ) in PV or IC and dual antiplatelet therapy.
Part C: To explore the different platelet activities of the above three sites in STEMI patients who are administrated antiplatelet thrombolysin or placebo in PV and dual antiplatelet therapy.
Detailed description
Part A:A total of 30 CAD patients are recruited.All patients are on loading dose of 300 mg clopidogrel followed by a maintenance dose of 75 mg/d for at least 5 days and a loading dose of 300 mg aspirin followed by a maintenance dose of 100 mg/d for at least 5 days. All patients plan to receive coronary arteriography (CAG) or percutaneous coronary intervention (PCI).The investigators sample blood from PV,PA and IC before PCI.Regional differences will be compared between blood samples from PV,PA and IC by light aggregometry (agonists: arachidonic acid, LTA-AA; adenosine diphosphat, LTA-ADP), VerifyNow P2Y12 assays. Differences between LTA and VerifyNow P2Y12-assay will also be compared.
Part B:A total of 30 STEMI patients are recruited.Patients are randomly assigned to 2 groups.A group(n=15) is given tirofiban through PV, the other group(n=15) is given through IC.All patients are on loading dose of 600 mg clopidogrel and 300 mg aspirin.All patients plan to receive emergency PCI. Group PV: a loading dose of 10ug/kg tirofiban is given in 3 min through PV,followed by a maintenance dose of 0.15ug/kg*min for 48h.Group IC: a loading dose of 10ug/kg tirofiban is given through IC,followed by a maintenance dose of 0.15ug/kg*min for 48h. Blood samples are collceted from PV, PA and IC before the injection of loading dose tirofiban , and 15min after the injection.Regional differences will be compared between blood samples from PV,PA and IC by LTA-AA; LTA-ADP, LTA-RIS(agonists:ristocetin),VerifyNow P2Y12 assays.
Part C:A total of 30 STEMI patients are recruited.Patients are randomly assigned to 2 groups.A group(n=15) is given antiplatelet thrombolysin(the frist antiplatelet drugs based on GP Ib receptor which completed the preclinical and phase I clinical studies,and already has entered phase II clinical studies) through PV, the other group(n=15) is given placebo through PV.All patients are on loading dose of 600 mg clopidogrel and 300 mg aspirin.All patients plan to receive emergency PCI.Both Groups are given in the same way , a loading dose of 5 IU/60kg in 5 min through PV,followed by a maintenance dose of 0.002 IU/kg/h for 48h. Blood samples are collceted from PV, PA and IC before the injection of loading dose of antiplatelet thrombolysin or placebo, and 15 min after the injection.Regional differences will be compared between blood samples from PV,PA and IC by LTA-AA; LTA-ADP, LTA-RIS and VerifyNow P2Y12 assays.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| dual antiplatelet therapy | Experimental | Drug: Clopidogrel, Drug: Aspirinclopidogrel +aspirin |
| tirofiban in PV | Experimental | Drug: tirofiban in PV, Drug: Aspirin, Drug: Clopidogrelclopidogrel +aspirin + tirofiban in PV |
| tirofiban in IC | Experimental | Drug: tirofiban in IC, Drug: Aspirin, Drug: Clopidogrelclopidogrel +aspirin +tirofiban in IC |
| antiplatelet thrombolysin | Experimental | Drug: antiplatelet thrombolysin, Drug: Aspirin, Drug: Clopidogrelclopidogrel +aspirin +antiplatelet thrombolysin |
| placebo | Placebo comparator | Drug: placebo, Drug: Aspirin, Drug: Clopidogrelclopidogrel +aspirin +placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- CAD patients plan to receive coronary arteriography (CAG) or percutaneous coronary intervention (PCI).
- Patient aged >18 years and ≦75 years old;
- Signed inform consent
Key exclusion criteria (5 listed)
- Allergy or intolerance to ASA, clopidogrel , tirofiban ,antiplatelet thrombolysin;
- Subjects at a high risk of bleeding (e.g. platelet count< 100*109/L, known bleeding diathesis , active peptic ulcer );
- Patients who are planning to take warfarin or drugs that potentially could interfere with the anti-platelet effects .
- severe hemodynamic instability
- severe liver and renal dysfunction
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 |
|---|---|---|
| tirofiban in PVAlso: GPⅡb/Ⅲa receptor antagonista loading dose of 10ug/kg tirofiban is given in 3 min through PV,followed by a maintenance dose of 0.15ug/kg*min for 48h. (clopidogrel 600 mg+aspirin( ASA) 300 mg)x1 day. | Drug | tirofiban in PV |
| tirofiban in ICAlso: GP IIb/IIIa receptor antagonista loading dose of 10ug/kg tirofiban is given in 3 min through IC,followed by a maintenance dose of 0.15ug/kg*min for 48h. (clopidogrel 600 mg+ ASA 300 mg)x1 day. | Drug | tirofiban in IC |
| antiplatelet thrombolysinAlso: GP Ib receptor antagonista loading dose of 5 IU/60kg in 5 min through PV,followed by a maintenance dose of 0.002 IU/kg/h for 48h. (clopidogrel 600 mg+ ASA 300 mg)x1 day. | Drug | antiplatelet thrombolysin |
| placeboa loading dose of 5 IU/60kg in 5 min through PV,followed by a maintenance dose of 0.002 IU/kg/h for 48h. (clopidogrel 600 mg+ ASA 300 mg)x1 day. | Drug | placebo |
| Clopidogrelloading dose of 300 mg clopidogrel followed by a maintenance dose of 75 mg/d for at least 5 days | Drug | dual antiplatelet therapy |
| Aspirinloading dose of 300 mg aspirin followed by a maintenance dose of 100 mg/d for at least 5 days. | Drug | antiplatelet thrombolysin, dual antiplatelet therapy, placebo, tirofiban in IC, tirofiban in PV |
| Clopidogrelloading dose of 600 mg clopidogrel followed by a maintenance dose of 75 mg/d for at least 5 days | Drug | antiplatelet thrombolysin, placebo, tirofiban in IC, tirofiban in PV |
Primary outcome
platelet aggregation
Time frame: 2 hours
Regional differences between blood samples from PV,PA and IC by LTA and VerifyNow P2Y12 assays.The results of LTA are reported in platelet aggregation rate（%）.Platelet aggregation was induced using 0.5 mg/ml arachidonic acid (AA) and 5 μmol/l ADP.The maximum aggregation achieved during an 8-minute period was used for analysis.The results of the VerifyNow P2Y12-assay are reported in P2Y12 reaction units (PRU).(using 20 μmol/l ADP as the agonist and 22 nmol/l prostag- landin E1 (PGE1). a value that uses iso- thrombin receptor-activating peptide to approximate a baseline off-drug platelet reactivity value, and percentage inhibition.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2017.
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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.
First Affiliated Hospital of Nanjing Medical University
Nanjing, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing tirofiban in PV, tirofiban in IC and antiplatelet thrombolysin in people with Coronary Artery Disease, run by The First Affiliated Hospital with Nanjing Medical University at 1 site 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 3 inclusion and 5 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 13 Mar 2017. 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 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. Some participants in this study may receive a placebo. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
platelet aggregation (time frame: 2 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 13 Mar 2017.