Acute Coronary SyndromePhase 4NCT04046029
Bivalirudin in Elderly Patients Undergoing Elective Percutaneous Coronary Intervention.
A Phase 4 study testing Bivalirudin and Heparin in people with Acute Coronary Syndrome and Percutaneous Coronary Intervention, run by The First Affiliated Hospital of Dalian Medical University at 1 site in China.
Trial summary
The study is an investigator-sponsored, prospective, multicenter, randomized, open-label study designed to compare efficacy and safety between bivalirudin and heparin in elderly patients with acute coronary syndrome undergoing elective percutaneous coronary intervention. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Acute Coronary Syndrome, Percutaneous Coronary Intervention, Aging
- What is being tested?
- Bivalirudin and Heparin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- 8 Jul 2019to 30 Jun 2021
- 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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age ≥75 years old;
- Planned elective PCI for patients with acute coronary syndrome;
- Life expectancy ≥ 1 year;
- Provide written informed consent.
Who cannot join
- Contraindications to angiography or PCI;
- Active bleeding or bleeding constitution, bleeding tendency, including GI or urinary tract hemorrhage (3 months), cerebral hemorrhage (6 months) or cerebral infarction history (3 months), etc;
- Other disease may lead to vascular lesions and secondary bleeding factors (such as active gastric ulcer, active ulcerative colitis, intra-cerebral mass, aneurysm, etc.);
- Severe renal insufficiency (eGFR < 30 mL/min/ 1.73 m2);
- Elevated AST, ALT level higher than three times of the normal upper limit;
- Advanced heart failure (NYHA classification grading of cardiac function ≥Ⅲ) Complicated with immune system diseases#
Show all 13Show fewer
- Abnormal hematopoietic system: platelet count < 100 × 109 / L or >700 × 109 / L, white blood cell count < 3×109/L etc;
- Suffering from acute infections ,infectious diseases or other serious diseases, such as malignant tumors;
- Known intolerance, or contraindication to any antithrombotic medication
- Known allergy to the study drugs and instruments (UFH, bivalirudin, aspirin and clopidogrel, stainless steel, contrast agents, etc.), or those allergic constitution.
- Non-cardiac co-morbid conditions are present that may result in protocol non-compliance;
- Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period;
- Patient's inability to fully cooperate with the study protocol
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Dalian Medical University
Dalian, 116011
Wei Huang, M.D., +86-411-83635963 ext. 3035, dyyykjb@126.com
Yinan Wang, +86-411-83635963 ext. 3015
About this study
Official title: Bivalirudin vs Heparin in Elderly Patients With Acute Coronary Syndrome Undergoing Elective Percutaneous Coronary Intervention
The study is an investigator-sponsored, prospective, multicenter, randomized, open-label study designed to compare efficacy and safety between bivalirudin and heparin in elderly patients with acute coronary syndrome undergoing elective percutaneous coronary intervention.
- Conditions
- Acute Coronary Syndrome, Percutaneous Coronary Intervention, Aging, Anticoagulants and Bleeding Disorders
- Being tested
- Bivalirudin, Heparin
- Keywords
- Acute Coronary Syndrome, Percutaneous Coronary Intervention, Elderly, Bivalirudin
- Medical subject headings
- Acute Coronary Syndrome, Hemostatic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BivalirudinDrug
Bivalirudin will be given as a bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg/h during the PCI procedure and for at least 30 minutes but no more than 4 hours afterwards. Following this mandatory infusion,a reduced-dose infusion (0.2 mg/kg/h) for up to 20 hours could be administered at physician discretion. An additional bivalirudin bolus of 0.3 mg/kg was given if the activated clotting time 5 minutes after the initial bolus was less than 225 seconds.
HeparinDrug
Heparin will be administered at a dose of 70 to 100 units per kilogram in patients not receiving glycoprotein IIb/IIIa inhibitors and at a dose of 50 to 70 units per kilogram in patients receiving glycoprotein IIb/IIIa inhibitors. Subsequent adjustment of the heparin dose on the basis of the activated clotting time will be left to the discretion of the treating physicians.
| Study group | Role | What they receive |
|---|---|---|
| Bivalirudin | Experimental | Not described Receives: Drug: Bivalirudin |
| Heparin | Active comparator | Not described Receives: Drug: Heparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiac events
A composite of cardiac death, reinfarction, heart failure,ischemic stroke,frequent post infarction angina, Ventricular tachycardia or fibrillation requiring electrical cardioversion or defibrillation.
Measured: 7 days
Major bleeding
BARC types 3-5 bleeding;TIMI major bleeding or GUSTO moderate to severe bleeding.
Measured: 7 days
Secondary outcomes (6)
Major adverse cardiac events
A composite of cardiac death, reinfarction, heart failure,ischemic stroke,frequent post infarction angina, Ventricular tachycardia or fibrillation requiring electrical cardioversion or defibrillation.
Measured: 30 days
Stent thrombosis ,TVR ,TLR
Rate of stent thrombosis,unplanned target-vessel revascularization and target lesion revascularisation.
Measured: 30 days
Major adverse cardiac events
A composite of cardiac death, reinfarction, heart failure,ischemic stroke,frequent post infarction angina, Ventricular tachycardia or fibrillation requiring electrical cardioversion or defibrillation.
Measured: 180 days
Stent thrombosis ,TVR ,TLR
rate of stent thrombosis,unplanned target-vessel revascularization and target lesion revascularisation
Measured: 180 days
Major bleeding
BARC types 3-5 bleeding;TIMI major bleeding or GUSTO moderate to severe bleeding.
Measured: 30 days
Major bleeding
BARC types 3-5 bleeding;TIMI major bleeding or GUSTO moderate to severe bleeding.
Measured: 180days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2019
- Study start8 Jul 2019
- Primary completion30 Jul 2020 (estimated)
- Study completion30 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Dalian Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Friendship Hospital
- Responsible party
- Sponsor
- Investigators
- Shaoke Meng, M.D., Principal investigator, The First Affiliated Hospital of Dalian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04046029
- Sponsor's protocol ID
- PJ-KS-KY-2019-38(X)
- Status last verified
- Jul 2019
- First submitted
- 2 Aug 2019
- Last updated
- 6 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
De Caterina R, Husted S, Wallentin L, Andreotti F, Arnesen H, Bachmann F, Baigent C, Huber K, Jespersen J, Kristensen SD, Lip GY, Morais J, Rasmussen LH, Siegbahn A, Verheugt FW, Weitz JI; European Society of Cardiology Working Group on Thrombosis Task Force on Anticoagulants in Heart Disease. Parenteral anticoagulants in heart disease: current status and perspectives (Section II). Position paper of the ESC Working Group on Thrombosis-Task Force on Anticoagulants in Heart Disease. Thromb Haemost. 2013 May;109(5):769-86. doi: 10.1160/TH12-06-0403. Epub 2013 Mar 28.
PubMed 23636477Hirsh J, Anand SS, Halperin JL, Fuster V; American Heart Association. AHA Scientific Statement: Guide to anticoagulant therapy: heparin: a statement for healthcare professionals from the American Heart Association. Arterioscler Thromb Vasc Biol. 2001 Jul;21(7):E9-9. doi: 10.1161/hq0701.093520. No abstract available.
PubMed 11451763Robson R, White H, Aylward P, Frampton C. Bivalirudin pharmacokinetics and pharmacodynamics: effect of renal function, dose, and gender. Clin Pharmacol Ther. 2002 Jun;71(6):433-9. doi: 10.1067/mcp.2002.124522.
PubMed 12087346
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bivalirudin vs Heparin in Elderly Patients With Acute Coronary Syndrome Undergoing Elective Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT04046029
- Acronym / sponsor ID
- PJ-KS-KY-2019-38(X)
- Conditions
- Acute Coronary Syndrome, Percutaneous Coronary Intervention, Aging, Anticoagulants and Bleeding Disorders
- Keywords
- Acute Coronary Syndrome, Percutaneous Coronary Intervention, Elderly, Bivalirudin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Dalian Medical UniversityUniversity, hospital or other
- Collaborators
- Beijing Friendship Hospital
- Study start
- 8 Jul 2019 (actual)
- Primary completion
- 30 Jul 2020 (estimated)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 6 Aug 2019 (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 study is an investigator-sponsored, prospective, multicenter, randomized, open-label study designed to compare efficacy and safety between bivalirudin and heparin in elderly patients with acute coronary syndrome undergoing elective percutaneous coronary intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bivalirudin | Experimental | Drug: Bivalirudin |
| Heparin | Active comparator | Drug: Heparin |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Age ≥75 years old;
- Planned elective PCI for patients with acute coronary syndrome;
- Life expectancy ≥ 1 year;
- Provide written informed consent.
Key exclusion criteria (13 listed)
- Contraindications to angiography or PCI;
- Active bleeding or bleeding constitution, bleeding tendency, including GI or urinary tract hemorrhage (3 months), cerebral hemorrhage (6 months) or cerebral infarction history (3 months), etc;
- Other disease may lead to vascular lesions and secondary bleeding factors (such as active gastric ulcer, active ulcerative colitis, intra-cerebral mass, aneurysm, etc.);
- Severe renal insufficiency (eGFR < 30 mL/min/ 1.73 m2);
- Elevated AST, ALT level higher than three times of the normal upper limit;
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 |
|---|---|---|
| BivalirudinBivalirudin will be given as a bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg/h during the PCI procedure and for at least 30 minutes but no more than 4 hours afterwards. Following this mandatory infusion,a reduced-dose infusion (0.2 mg/kg/h) for up to 20 hours could be administered at physician discretion. An additional bivalirudin bolus of 0.3 mg/kg was given if the activated clotting time 5 minutes after the initial bolus was less than 225 seconds. | Drug | Bivalirudin |
| HeparinHeparin will be administered at a dose of 70 to 100 units per kilogram in patients not receiving glycoprotein IIb/IIIa inhibitors and at a dose of 50 to 70 units per kilogram in patients receiving glycoprotein IIb/IIIa inhibitors. Subsequent adjustment of the heparin dose on the basis of the activated clotting time will be left to the discretion of the treating physicians. | Drug | Heparin |
Primary outcome
Major adverse cardiac events
Time frame: 7 days
A composite of cardiac death, reinfarction, heart failure,ischemic stroke,frequent post infarction angina, Ventricular tachycardia or fibrillation requiring electrical cardioversion or defibrillation.
Major bleeding
Time frame: 7 days
BARC types 3-5 bleeding;TIMI major bleeding or GUSTO moderate to severe bleeding.
6 secondary outcomes
Major adverse cardiac events
Time frame: 30 days
Stent thrombosis ,TVR ,TLR
Time frame: 30 days
Major adverse cardiac events
Time frame: 180 days
Stent thrombosis ,TVR ,TLR
Time frame: 180 days
Major bleeding
Time frame: 30 days
Major bleeding
Time frame: 180days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2019.
- Background: PubMed 23636477De Caterina R, Husted S, Wallentin L, Andreotti F, Arnesen H, Bachmann F, Baigent C, Huber K, Jespersen J, Kristensen SD, Lip GY, Morais J, Rasmussen LH, Siegbahn A, Verheugt FW, Weitz JI; European Society of Cardiology Working Group on Thrombosis Task Force on Anticoagulants in Heart Disease. Parenteral anticoagulants in heart disease: current status and perspectives (Section II). Position paper of the ESC Working Group on Thrombosis-Task Force on Anticoagulants in Heart Disease. Thromb Haemost. 2013 May;109(5):769-86. doi: 10.1160/TH12-06-0403. Epub 2013 Mar 28.
- Background: PubMed 11451763Hirsh J, Anand SS, Halperin JL, Fuster V; American Heart Association. AHA Scientific Statement: Guide to anticoagulant therapy: heparin: a statement for healthcare professionals from the American Heart Association. Arterioscler Thromb Vasc Biol. 2001 Jul;21(7):E9-9. doi: 10.1161/hq0701.093520. No abstract available.
- Background: PubMed 12087346Robson R, White H, Aylward P, Frampton C. Bivalirudin pharmacokinetics and pharmacodynamics: effect of renal function, dose, and gender. Clin Pharmacol Ther. 2002 Jun;71(6):433-9. doi: 10.1067/mcp.2002.124522.
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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.
Shaoke Meng, M.D. principal investigator
The First Affiliated Hospital of Dalian Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bivalirudin and Heparin in people with Acute Coronary Syndrome and Percutaneous Coronary Intervention, run by The First Affiliated Hospital of Dalian 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 4 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: status not confirmed, as of the sponsor's last update on 6 Aug 2019. 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. 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 Shaoke Meng, M.D. (+86 18098875772, shaokemeng@dmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major adverse cardiac events (time frame: 7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04046029, which also lists 3 linked publications.
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 6 Aug 2019.