Clinical Trial Results:
Ticagrelor and absorb bioresorbable vascular scaffold implantation for recovery of vascular function after successful chronic total occlusion recanalization
Summary
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EudraCT number |
2013-002675-17 |
Trial protocol |
ES |
Global end of trial date |
15 May 2019
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Results information
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Results version number |
v1(current) |
This version publication date |
03 May 2021
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First version publication date |
03 May 2021
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Other versions |
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Summary report(s) |
final results trial design main findings |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
TIGER-BVS
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
IDIBAPS
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Sponsor organisation address |
Carrer De Villaroel 170, Barcellona, Spain, 08036
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Public contact |
Servicio de Cardología, Hospital Clínic de Barcelona, 0034 9322754002042, sabrugal@clinic.ub.es
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Scientific contact |
Servicio de Cardología, Hospital Clínic de Barcelona, 0034 9322754002042, sabrugal@clinic.ub.es
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
21 Nov 2019
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
15 May 2019
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Global end of trial reached? |
Yes
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Global end of trial date |
15 May 2019
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To determine the effects of ticagrelor vs. clopidogrel on the adenosine-induced physiological vascular function of the coronary segment distal to a coronary chronic total occlusion immediately after percutaneous recanalization.
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Protection of trial subjects |
Subjects were strictly followed up
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
05 May 2014
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Long term follow-up planned |
Yes
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Long term follow-up rationale |
Safety, Efficacy, Ethical reason, Regulatory reason, Scientific research | ||
Long term follow-up duration |
3 Years | ||
Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Spain: 100
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Worldwide total number of subjects |
100
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EEA total number of subjects |
100
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
78
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From 65 to 84 years |
22
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85 years and over |
0
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Recruitment
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Recruitment details |
- | |||||||||
Pre-assignment
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Screening details |
screening was with few failed screening patients | |||||||||
Period 1
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Period 1 title |
overall trial (overall period)
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | |||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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clopidogrell | |||||||||
Arm description |
- | |||||||||
Arm type |
clopidogrel | |||||||||
Investigational medicinal product name |
No investigational medicinal product assigned in this arm
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Arm title
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ticagrelor | |||||||||
Arm description |
- | |||||||||
Arm type |
ticagrelor | |||||||||
Investigational medicinal product name |
ticagrelor
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Buccal tablet
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Routes of administration |
Oral use
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Dosage and administration details |
loading dose of 180 mg, followed by 90 mg bid
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End points reporting groups
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Reporting group title |
clopidogrell
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Reporting group description |
- | ||
Reporting group title |
ticagrelor
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Reporting group description |
- |
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End point title |
coronary blood flow | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
baseline
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Statistical analysis title |
main endpoint analysis | ||||||||||||
Comparison groups |
clopidogrell v ticagrelor
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Number of subjects included in analysis |
100
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
< 0.05 | ||||||||||||
Method |
Wilcoxon (Mann-Whitney) | ||||||||||||
Parameter type |
AUC | ||||||||||||
Point estimate |
10000
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Confidence interval |
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level |
90% | ||||||||||||
sides |
2-sided
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lower limit |
1000 | ||||||||||||
upper limit |
20000 | ||||||||||||
Variability estimate |
Standard deviation
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Adverse events information [1]
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Timeframe for reporting adverse events |
3 years
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Assessment type |
Systematic | ||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||
Dictionary version |
1.0
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Frequency threshold for reporting non-serious adverse events: 5% | |||
Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: events were less than 1% |
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |