Acute Coronary SyndromesPhase 4CocktailIINCT02592720
Cocktail Injection Improves Outcomes of FFR Guided PCI
A Phase 4 study testing cocktail, FFR and QCA guided group in people with Acute Coronary Syndromes, run by Xijing Hospital at 1 site in China.
Trial summary
This is a randomized, single blind, controlled study of intracoronary cocktail injection before fractional flow reserve (FFR) measurement when guiding percutaneous coronary intervention (PCI) in patients with acute coronary syndrome (ACS). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Coronary Syndromes
- What is being tested?
- cocktail, FFR and QCA guided group
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- Oct 2015to Oct 2017
- 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
- patients with a clinical diagnosis of recent ACS within 5 days
Who cannot join
- haemodynamic instability
- intolerance to anti-platelet drugs
- ineligible for coronary revascularization
- a treatment plan for non-coronary heart surgery (e.g. valve surgery)
- a history of prior PCI or CABG
- angiographic evidence of severe (e.g. diffuse calcification) or mild (<30% severity) coronary disease
- a life expectancy less than 1 year
- adenosine allergy
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xijing hospital
Xi'an, Shaanxi, 710032
Dongdong Sun, M.D.,Ph.D, 86 18691569930, wintersun3@gmail.com
About this study
Official title: Intracoronary Cocktail Injection Improves Outcomes of Fractional Flow Reserve Guided Percutaneous Coronary Intervention in Patients With Acute Coronary Syndrom (ACS)
This is a randomized, single blind, controlled study of intracoronary cocktail injection before fractional flow reserve (FFR) measurement when guiding percutaneous coronary intervention (PCI) in patients with acute coronary syndrome (ACS).
Read the detailed description
This is a randomized, single blind, controlled study of intracoronary cocktail injection before fractional flow reserve (FFR) measurement when guiding percutaneous coronary intervention (PCI) in patients with acute coronary syndrome (ACS). Patients with ACS will be randomized into the cocktail plus FFR guided group or the QCA guided group. The primary outcome of the cocktail II study is the composite of death, myocardial infarction, class IV heart failure and target vessel revascularization within 1 year. The secondary outcome of the cocktail II study include left ventricular function, quality of life, stroke or life-threatening bleeding within 1 year.
- Conditions
- Acute Coronary Syndromes
- Being tested
- cocktail, FFR, QCA guided group
- Keywords
- Acute Coronary Syndromes, Fractional Flow Reserve, Percutaneous Coronary Intervention
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cocktailDrug
Also called cocktail (tirofiban, bivalirudin, tenecteplase)
Intracoronary cocktail injection before fractional flow reserve (FFR) measurement. Percutaneous Coronary Intervention (PCI) strategy is decided by FFR value in patients with acute coronary syndrome (ACS).
FFRDevice
Also called pressure wire (St. Jude Medical, Inc.)
Percutaneous Coronary Intervention (PCI) strategy is decided by FFR value in patients with acute coronary syndrome (ACS).
QCA guided groupDevice
Percutaneous Coronary Intervention (PCI) strategy is decided by QCA value in patients with acute coronary syndrome (ACS).
| Study group | Role | What they receive |
|---|---|---|
| Cocktail plus FFR guided group | Experimental | Intracoronary cocktail injection before fractional flow reserve (FFR) measurement. Percutaneous Coronary Intervention (PCI) strategy is decided by FFR value in patients with acute coronary syndrome (ACS). Receives: Drug: cocktail; Device: FFR |
| QCA guided group | Placebo comparator | Percutaneous Coronary Intervention (PCI) strategy is decided by QCA value in patients with acute coronary syndrome (ACS). Receives: Device: QCA guided group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiac events
number of participants with death, myocardial infarction or class IV heart failure and target vessel revascularization revascularization
Measured: 1 year
Secondary outcomes (5)
left ventricular function
left ventricular ejection fraction evaluated by ultrasound and MRI
Measured: 1 year
Seattle Angina Questionnaire scores
Seattle Angina Questionnaire scores
Measured: 1 year
Canadian Cardiovascular Society (CCS) Functional Angina classification
Canadian Cardiovascular Society (CCS) Functional Angina classification
Measured: 1 year
6-minute walk distance (6MWD)
6-minute walk distance (6MWD)
Measured: 1 year
stroke
number of participants with stroke
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionOct 2017 (estimated)
- Study completionOct 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromesStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, sunddong, Xijing Hospital
- Investigators
- Dongdong Sun, M.D.,Ph.D., Principal investigator, Air Force Military Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02592720
- Sponsor's protocol ID
- Cocktail II-FFR ACS
- Acronym
- CocktailII
- Status last verified
- Oct 2015
- First submitted
- 27 Oct 2015
- Last updated
- 30 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intracoronary Cocktail Injection Improves Outcomes of Fractional Flow Reserve Guided Percutaneous Coronary Intervention in Patients With Acute Coronary Syndrom (ACS)
- ClinicalTrials.gov ID
- NCT02592720
- Acronym / sponsor ID
- CocktailII / Cocktail II-FFR ACS
- Conditions
- Acute Coronary Syndromes
- Keywords
- Acute Coronary Syndromes, Fractional Flow Reserve, Percutaneous Coronary Intervention
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Oct 2017 (estimated)
- First posted
- 30 Oct 2015 (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.
This is a randomized, single blind, controlled study of intracoronary cocktail injection before fractional flow reserve (FFR) measurement when guiding percutaneous coronary intervention (PCI) in patients with acute coronary syndrome (ACS).
Detailed description
This is a randomized, single blind, controlled study of intracoronary cocktail injection before fractional flow reserve (FFR) measurement when guiding percutaneous coronary intervention (PCI) in patients with acute coronary syndrome (ACS). Patients with ACS will be randomized into the cocktail plus FFR guided group or the QCA guided group. The primary outcome of the cocktail II study is the composite of death, myocardial infarction, class IV heart failure and target vessel revascularization within 1 year. The secondary outcome of the cocktail II study include left ventricular function, quality of life, stroke or life-threatening bleeding within 1 year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cocktail plus FFR guided group | Experimental | Drug: cocktail, Device: FFRIntracoronary cocktail injection before fractional flow reserve (FFR) measurement. Percutaneous Coronary Intervention (PCI) strategy is decided by FFR value in patients with acute coronary syndrome (ACS). |
| QCA guided group | Placebo comparator | Device: QCA guided groupPercutaneous Coronary Intervention (PCI) strategy is decided by QCA value in patients with acute coronary syndrome (ACS). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with a clinical diagnosis of recent ACS within 5 days
Key exclusion criteria (8 listed)
- haemodynamic instability
- intolerance to anti-platelet drugs
- ineligible for coronary revascularization
- a treatment plan for non-coronary heart surgery (e.g. valve surgery)
- a history of prior PCI or CABG
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 |
|---|---|---|
| cocktailAlso: cocktail (tirofiban, bivalirudin, tenecteplase)Intracoronary cocktail injection before fractional flow reserve (FFR) measurement. Percutaneous Coronary Intervention (PCI) strategy is decided by FFR value in patients with acute coronary syndrome (ACS). | Drug | Cocktail plus FFR guided group |
| FFRAlso: pressure wire (St. Jude Medical, Inc.)Percutaneous Coronary Intervention (PCI) strategy is decided by FFR value in patients with acute coronary syndrome (ACS). | Device | Cocktail plus FFR guided group |
| QCA guided groupPercutaneous Coronary Intervention (PCI) strategy is decided by QCA value in patients with acute coronary syndrome (ACS). | Device | QCA guided group |
Primary outcome
Major adverse cardiac events
Time frame: 1 year
number of participants with death, myocardial infarction or class IV heart failure and target vessel revascularization revascularization
5 secondary outcomes
left ventricular function
Time frame: 1 year
Seattle Angina Questionnaire scores
Time frame: 1 year
Canadian Cardiovascular Society (CCS) Functional Angina classification
Time frame: 1 year
6-minute walk distance (6MWD)
Time frame: 1 year
stroke
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2015.
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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.
Dongdong Sun, M.D.,Ph.D. principal investigator
Air Force Military Medical University, China
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 cocktail, FFR and QCA guided group in people with Acute Coronary Syndromes, run by Xijing Hospital 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 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: status not confirmed, as of the sponsor's last update on 30 Oct 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wanrong Man, MD (86 29 84775183, manwanrong@gmail.com), 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: 1 year). 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 30 Oct 2015.