Conservative PharmacotherapyCPVsSPCINCT02154919
Non-culprit Vessels for ST-Segment Elevation Myocardial Infarction
An observational study of Conservative Pharmacotherapy and Staged Percutaneous Coronary Intervention, run by Beijing Shijitan Hospital, Capital Medical University at 1 site in China.
Trial summary
To compare the different effect of conservative pharmacotherapy and Staged Percutaneous Coronary Intervention (SPCI) on significant non-culprit lesions in patients with ST-segment elevation myocardial infarction (STEMI) at presentation remains controversial Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Conservative Pharmacotherapy, Staged Percutaneous Coronary Intervention, Non-culprit Vessels
- What is being tested?
- Percutaneous coronary intervention
- Type of treatment
- Surgery or procedure
- How many people
- 306 participants
- Where
- 1 siteChina
- Study dates
- Apr 2011to Dec 2013
- Phase
- Observational
- 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
Study population: STEMI patients after culprit vessels treated by PPCI
Who may be able to join
- age 18 to 75 with continuous ischemic chest pain for ≥ 30 minutes and ST-segment of electrocardiographic leads between V2 and V3 elevated ≥ 0.2 mV (or ≥ 0.1 mV in ≥ 2 other continuous electrocardiographic leads), cardiac troponin I (cTn I) elevation of > 0.05 ng/ml, coronary arteriography within 12 hours after the onset of symptoms indicating lesion in culprit vessel with thrombolysis in myocardial infarction (TIMI) flow grade 0 to 1, merely underwent PPCI. Additionally, coronary arteriography corroborates lesions in non-culprit vessel (Besides the culprit vessel, there are ≥ 70% stenoses in one or more coronary vessels in which diameters were ≥ 2 mm).
Who cannot join
- left main coronary artery disease, cardiogenic shock, complete left bundle branch block (CLBBB) PPCI treated culprit and non-culprit vessels, PPCI failure patients with postsurgical haemodynamic instability or spontaneous ischemia, ≥ 70% stenoses of vessels remained during the hospitalization after staged PCI, history of PCI or Coronary Artery Bypass Grafting (CABG), history of chronic cardiac failure, bleeding diathesis, prior administration of thrombolytic therapy, known thrombopenia or leucopenia, sever liver and kidney dysfunction, active infection, immune system and connective tissue diseases, known contraindications to aspirin or heparin, life expectancy < 1 year, had major procedure within 3 months, uncontrolled hypertension, ischemic stroke within 30 days, hemorrhagic stroke, intracranial diseases including and arteriovenous malformation, extensive traumatic cerebral infarction within 6 weeks, oral anticoagulant therapy, severe myocardial infarction related complications and perioperative death
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Conservative Pharmacotherapy Versus Staged Percutaneous Coronary Intervention on Non-culprit Vessels for ST-Segment Elevation Myocardial Infarction Patients With Multivessel Disease
To compare the different effect of conservative pharmacotherapy and Staged Percutaneous Coronary Intervention (SPCI) on significant non-culprit lesions in patients with ST-segment elevation myocardial infarction (STEMI) at presentation remains controversial
- Conditions
- Conservative Pharmacotherapy, Staged Percutaneous Coronary Intervention, Non-culprit Vessels, ST-Segment Elevation Myocardial Infarction
- Being tested
- Percutaneous coronary intervention
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous coronary interventionProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| complete revascularization group | this group underwent second PCI procedure on the non-culprit vessels and reveived 100-120 IU/kg unfractionated heparin during PPCI, followed by 3 days administration of low molecular weight heparin or Fondaparinux sodium after procedure. Patients in the CP group and CR group after second PCI procedure were given conservative medicine such as Statins which were not contraindicated to the patients. Receives: Procedure: Percutaneous coronary intervention | |
| conservative pharmacotherapy group | patients in conservative group undergoing pharmacotherapy after PPCI. The drugs were the same between two groups. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Adverse Cardiovascular Events
Measured: 360days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2014 (estimated)
- Study startApr 2011
- Primary completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Conservative PharmacotherapyStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 306 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Shijitan Hospital, Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peng Jian Jun, Beijing Shijitan Hospital, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02154919
- Sponsor's protocol ID
- CPVsSPCI
- Acronym
- CPVsSPCI
- Status last verified
- May 2014
- First submitted
- 31 May 2014
- Last updated
- 3 Jun 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conservative Pharmacotherapy Versus Staged Percutaneous Coronary Intervention on Non-culprit Vessels for ST-Segment Elevation Myocardial Infarction Patients With Multivessel Disease
- ClinicalTrials.gov ID
- NCT02154919
- Acronym / sponsor ID
- CPVsSPCI / CPVsSPCI
- Conditions
- Conservative Pharmacotherapy, Staged Percutaneous Coronary Intervention, Non-culprit Vessels, ST-Segment Elevation Myocardial Infarction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 306 participants (actual)
- Lead sponsor
- Beijing Shijitan Hospital, Capital Medical UniversityUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Dec 2013 (actual)
- First posted
- 3 Jun 2014 (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.
To compare the different effect of conservative pharmacotherapy and Staged Percutaneous Coronary Intervention (SPCI) on significant non-culprit lesions in patients with ST-segment elevation myocardial infarction (STEMI) at presentation remains controversial
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| complete revascularization group | – | Procedure: Percutaneous coronary interventionthis group underwent second PCI procedure on the non-culprit vessels and reveived 100-120 IU/kg unfractionated heparin during PPCI, followed by 3 days administration of low molecular weight heparin or Fondaparinux sodium after procedure. Patients in the CP group and CR group after second PCI procedure were given conservative medicine such as Statins which were not contraindicated to the patients. |
| conservative pharmacotherapy group | – | –patients in conservative group undergoing pharmacotherapy after PPCI. The drugs were the same between two groups. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- STEMI patients after culprit vessels treated by PPCI
Key inclusion criteria (1 listed)
- age 18 to 75 with continuous ischemic chest pain for ≥ 30 minutes and ST-segment of electrocardiographic leads between V2 and V3 elevated ≥ 0.2 mV (or ≥ 0.1 mV in ≥ 2 other continuous electrocardiographic leads), cardiac troponin I (cTn I) elevation of > 0.05 ng/ml, coronary arteriography within 12 hours after the onset of symptoms indicating lesion in culprit vessel with thrombolysis in myocardial infarction (TIMI) flow grade 0 to 1, merely underwent PPCI. Additionally, coronary arteriography corroborates lesions in non-culprit vessel (Besides the culprit vessel, there are ≥ 70% stenoses in one or more coronary vessels in which diameters were ≥ 2 mm).
Key exclusion criteria (1 listed)
- left main coronary artery disease, cardiogenic shock, complete left bundle branch block (CLBBB) PPCI treated culprit and non-culprit vessels, PPCI failure patients with postsurgical haemodynamic instability or spontaneous ischemia, ≥ 70% stenoses of vessels remained during the hospitalization after staged PCI, history of PCI or Coronary Artery Bypass Grafting (CABG), history of chronic cardiac failure, bleeding diathesis, prior administration of thrombolytic therapy, known thrombopenia or leucopenia, sever liver and kidney dysfunction, active infection, immune system and connective tissue diseases, known contraindications to aspirin or heparin, life expectancy < 1 year, had major procedure within 3 months, uncontrolled hypertension, ischemic stroke within 30 days, hemorrhagic stroke, intracranial diseases including and arteriovenous malformation, extensive traumatic cerebral infarction within 6 weeks, oral anticoagulant therapy, severe myocardial infarction related complications and perioperative death
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 |
|---|---|---|
| Percutaneous coronary intervention | Procedure or surgery | complete revascularization group |
Primary outcome
Major Adverse Cardiovascular Events
Time frame: 360days
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 3 Jun 2014.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Conservative Pharmacotherapy and Staged Percutaneous Coronary Intervention, run by Beijing Shijitan Hospital, Capital 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 1 inclusion and 1 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 3 Jun 2014. 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.
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?
Major Adverse Cardiovascular Events (time frame: 360days). 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 3 Jun 2014.