Coronary Artery DiseasePhase 4PETITIONNCT01498003
Tirofiban in Stenting for Long Coronary Lesion
A Phase 4 study testing tirofiban and normal saline solution in people with Coronary Artery Disease, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
Periprocedural myonecrosis or infarction are associated with short, intermediate, and long term adverse outcomes. Previous study indicated 12.6% of patients suffered a peri-procedural CK-MB rise by overlapping use of drug-eluting stents for long coronary lesions. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- tirofiban and normal saline solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 748 participants
- Where
- 1 siteChina
- Study dates
- Nov 2011to Jun 2014
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18y~80y, with symptomatic coronary disease
- At least one lesion length more than 40mm to be treated by overlapping drug-eluting stents in major epicardial coronary vessel
Who cannot join
- Aspirin or clopidogrel intolerance
- Lesions length less than 40mm, or overlapping stent length less than 40mm
- Bifurcation lesions need to be treated by two stents
- Patients with acute coronary syndrome and elevated baseline cardiac enzyme (CK-MB)
- Left ventricular ejection fraction less than 0.35
- Baseline estimated GFR less than 30
- Estimated life time less than one year
- Refuse to sign the informed consent
Trial locations and contacts
1 site in 1 country.
China1 site
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200025
About this study
Official title: Safety and Efficacy of Peri-procedural Use of Tirofiban in Elective Percutaneous Coronary Intervention for Long Coronary Lesions With Overlapping Drug-Eluting Stent
Periprocedural myonecrosis or infarction are associated with short, intermediate, and long term adverse outcomes. Previous study indicated 12.6% of patients suffered a peri-procedural CK-MB rise by overlapping use of drug-eluting stents for long coronary lesions. Here the investigators hypothesize that peri-procedural use of tirofiban could reduce the occurrence of periprocedural infarciton in elective patients with long coronary lesions treated by overlapping use of drug-eluting stents.
Read the detailed description
According to the results of 12.6% occurrence of peri-procedural myocardial infarction after long stent implantation by previous report[International Journal of Cardiology 2009;134: 231-237], the investigator hypothesize the 50% reduction of peri-procedural MI by using tirofiban. Three hundred and sixty-nine patients in each group are needed to reach 80% of power with α 0.05.
- Conditions
- Coronary Artery Disease
- Being tested
- tirofiban, normal saline solution
- Keywords
- coronary disease, stents, thrombosis, myocardial infarction, prognosis
- Medical subject headings
- Coronary Artery Disease, Coronary Disease, Thrombosis, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tirofibanDrug
Also called Xinweining, Grand Pharmaceutical Group, Wuhan, China
10μg/kg bolus followed by 0.15μg/kg/min maintenance infusion for 12h
normal saline solutionDrug
same use as tirofiban
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | normal saline was applied to those randomized to control group, with same use as tirofiban Receives: Drug: normal saline solution |
| Tirofiban group | Experimental | after angioram, and before guiding catheter engagement: 10μg/kg bolus followed by 0.15μg/kg/min maintenance infusion Receives: Drug: tirofiban |
What is being measured
The primary outcome is the main question the study is designed to answer.
periprocedural infarction
definition of periprocedural MI is a CK elevation >3 times the upper limit of normal.
Measured: 12h after procedure
Secondary outcomes (2)
major bleeding
The safety outcome of major bleeding according to the Thrombolysis in Myocardial Infarction (TIMI) definition
Measured: during hospitalization (up to 2 weeks)
major adverse cardiac event
major adverse cardiac event (MACE) includes cardiac death, target vessel revascularization, and re-occurrence of myocardial infarction after discharge
Measured: one year after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2011 (estimated)
- Study startNov 2011
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong University School of MedicineThe 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
- None (open label)
- Enrolment
- 748 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhang Qi, MD, Shanghai Jiao Tong University School of Medicine
- Investigators
- WeiFeng Shen, PhD, Study chair, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01498003
- Sponsor's protocol ID
- 20111211
- Acronym
- PETITION
- Status last verified
- Jul 2015
- First submitted
- 11 Dec 2011
- Last updated
- 14 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Zhang Q, Wang XL, Liao ML, Hu J, Yang ZK, Ding FH, Zhang JS, Du R, Zhu TQ, Shen WF, Zhang RY. Periprocedural use of tirofiban in elective percutaneous coronary intervention for long coronary lesions in stable patients with overlapping drug-eluting stents--the PETITION study: a prospective, randomized, multicenter study. Catheter Cardiovasc Interv. 2015 Mar;85 Suppl 1:762-9. doi: 10.1002/ccd.25864.
PubMed 25630513
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Peri-procedural Use of Tirofiban in Elective Percutaneous Coronary Intervention for Long Coronary Lesions With Overlapping Drug-Eluting Stent
- ClinicalTrials.gov ID
- NCT01498003
- Acronym / sponsor ID
- PETITION / 20111211
- Conditions
- Coronary Artery Disease
- Keywords
- coronary disease, stents, thrombosis, myocardial infarction, prognosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 748 participants (actual)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 23 Dec 2011 (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.
Periprocedural myonecrosis or infarction are associated with short, intermediate, and long term adverse outcomes. Previous study indicated 12.6% of patients suffered a peri-procedural CK-MB rise by overlapping use of drug-eluting stents for long coronary lesions. Here the investigators hypothesize that peri-procedural use of tirofiban could reduce the occurrence of periprocedural infarciton in elective patients with long coronary lesions treated by overlapping use of drug-eluting stents.
Detailed description
According to the results of 12.6% occurrence of peri-procedural myocardial infarction after long stent implantation by previous report[International Journal of Cardiology 2009;134: 231-237], the investigator hypothesize the 50% reduction of peri-procedural MI by using tirofiban. Three hundred and sixty-nine patients in each group are needed to reach 80% of power with α 0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Drug: normal saline solutionnormal saline was applied to those randomized to control group, with same use as tirofiban |
| Tirofiban group | Experimental | Drug: tirofibanafter angioram, and before guiding catheter engagement: 10μg/kg bolus followed by 0.15μg/kg/min maintenance infusion |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age between 18y~80y, with symptomatic coronary disease
- At least one lesion length more than 40mm to be treated by overlapping drug-eluting stents in major epicardial coronary vessel
Key exclusion criteria (8 listed)
- Aspirin or clopidogrel intolerance
- Lesions length less than 40mm, or overlapping stent length less than 40mm
- Bifurcation lesions need to be treated by two stents
- Patients with acute coronary syndrome and elevated baseline cardiac enzyme (CK-MB)
- Left ventricular ejection fraction less than 0.35
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 |
|---|---|---|
| tirofibanAlso: Xinweining, Grand Pharmaceutical Group, Wuhan, China10μg/kg bolus followed by 0.15μg/kg/min maintenance infusion for 12h | Drug | Tirofiban group |
| normal saline solutionsame use as tirofiban | Drug | Control group |
Primary outcome
periprocedural infarction
Time frame: 12h after procedure
definition of periprocedural MI is a CK elevation >3 times the upper limit of normal.
2 secondary outcomes
major bleeding
Time frame: during hospitalization (up to 2 weeks)
major adverse cardiac event
Time frame: one year after procedure
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 14 Jul 2015.
- Derived from this study: PubMed 25630513Zhang Q, Wang XL, Liao ML, Hu J, Yang ZK, Ding FH, Zhang JS, Du R, Zhu TQ, Shen WF, Zhang RY. Periprocedural use of tirofiban in elective percutaneous coronary intervention for long coronary lesions in stable patients with overlapping drug-eluting stents--the PETITION study: a prospective, randomized, multicenter study. Catheter Cardiovasc Interv. 2015 Mar;85 Suppl 1:762-9. doi: 10.1002/ccd.25864.
- published resultsLink provided by the sponsor.
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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.
WeiFeng Shen, PhD study chair
Ruijin Hospital
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 tirofiban and normal saline solution in people with Coronary Artery Disease, run by Shanghai Jiao Tong University School of Medicine 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 2 inclusion and 8 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 14 Jul 2015. 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 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?
periprocedural infarction (time frame: 12h after procedure). 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 NCT01498003, which also lists 1 linked publication.
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 14 Jul 2015; AzTrials last refreshed its copy on 6 Nov 2026.