Trial Outcomes & Findings for SPARK: Safety Study of Pradaxa in Atrial Fibrillation Patients by Regulatory Requirement of Korea (NCT NCT01774370)
NCT ID: NCT01774370
Last Updated: 2019-03-08
Results Overview
Occurrence of adverse events(Including unexpected adverse events, serious adverse events, drug-related adverse events, adverse events leading to discontinuation and adverse events by intensity, outcome of the event, causality). Number analyzed presents the "Number of participants with Adverse events"
Recruitment status
COMPLETED
Target enrollment
3182 participants
Primary outcome timeframe
up to 26 weeks
Results posted on
2019-03-08
Participant Flow
This study is a prospective, non-interventional, open-label, multi-centre study.
All subjects were screened for eligibility to participate in the trial. Subjects attended a specialist sites which ensured that they met all strictly implemented inclusion/exclusion criteria. Subjects were not to be entered to trial treatment if any one of the specific entry criteria was violated.
Participant milestones
| Measure |
Pradaxa Group
Physician carefully reviewed the special precautions for use in patients with risk of bleeding before determining the dose of Pradaxa and patients were prescribed dabigatran dose for 24±2 weeks from the options described below:
* Dabigatran etexilate mesilate 110 mg b.i.d. (oral administration of one capsule twice daily )
* Dabigatran etexilate mesilate 150 mg b.i.d. (oral administration of one capsule twice daily)
|
|---|---|
|
Overall Study
STARTED
|
3182
|
|
Overall Study
COMPLETED
|
3053
|
|
Overall Study
NOT COMPLETED
|
129
|
Reasons for withdrawal
| Measure |
Pradaxa Group
Physician carefully reviewed the special precautions for use in patients with risk of bleeding before determining the dose of Pradaxa and patients were prescribed dabigatran dose for 24±2 weeks from the options described below:
* Dabigatran etexilate mesilate 110 mg b.i.d. (oral administration of one capsule twice daily )
* Dabigatran etexilate mesilate 150 mg b.i.d. (oral administration of one capsule twice daily)
|
|---|---|
|
Overall Study
Never taken the PRADAXA during the study
|
4
|
|
Overall Study
Administered prior to the contract date
|
4
|
|
Overall Study
Subjects of contraindications
|
34
|
|
Overall Study
Violated inclusion/exclusion criteria
|
53
|
|
Overall Study
Follow-up failure
|
34
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Pradaxa Group
n=3053 Participants
Physician carefully reviewed the special precautions for use in patients with risk of bleeding before determining the dose of Pradaxa and patients were prescribed dabigatran dose for 24±2 weeks from the options described below:
* Dabigatran etexilate mesilate 110 mg b.i.d. (oral administration of one capsule twice daily )
* Dabigatran etexilate mesilate 150 mg b.i.d. (oral administration of one capsule twice daily)
|
|---|---|
|
Age, Continuous
|
70.26 years
STANDARD_DEVIATION 9.64 • n=3053 Participants
|
|
Sex: Female, Male
Female
|
1201 Participants
n=3053 Participants
|
|
Sex: Female, Male
Male
|
1852 Participants
n=3053 Participants
|
PRIMARY outcome
Timeframe: up to 26 weeksPopulation: Safety analyses will be based on all patients treated, i.e. all patients who received at least one dose of Pradaxa.
Occurrence of adverse events(Including unexpected adverse events, serious adverse events, drug-related adverse events, adverse events leading to discontinuation and adverse events by intensity, outcome of the event, causality). Number analyzed presents the "Number of participants with Adverse events"
Outcome measures
| Measure |
Pradaxa Group
n=672 Participants
Physician carefully reviewed the special precautions for use in patients with risk of bleeding before determining the dose of Pradaxa and patients were prescribed dabigatran dose for 24±2 weeks from the options described below:
* Dabigatran etexilate mesilate 110 mg b.i.d. (oral administration of one capsule twice daily )
* Dabigatran etexilate mesilate 150 mg b.i.d. (oral administration of one capsule twice daily)
|
|---|---|
|
Occurrence of Adverse Events(Including Unexpected Adverse Events, Serious Adverse Events, Drug-related Adverse Events, Adverse Events Leading to Discontinuation and Adverse Events by Intensity, Outcome of the Event, Causality)
|
871 Adverse events
|
SECONDARY outcome
Timeframe: up to 26 weeksPopulation: Effectiveness Analysis set: Effectiveness analysis will be performed to the patients who have been on Pradaxa more than 12 weeks (in case of long-term follow up, 24 weeks).
Stroke was defined as an acute episode of focal or global neurological dysfunction caused by brain, spinal cord, or retinal vascular injury as a result of haemorrhage or infarction.
Outcome measures
| Measure |
Pradaxa Group
n=2311 Participants
Physician carefully reviewed the special precautions for use in patients with risk of bleeding before determining the dose of Pradaxa and patients were prescribed dabigatran dose for 24±2 weeks from the options described below:
* Dabigatran etexilate mesilate 110 mg b.i.d. (oral administration of one capsule twice daily )
* Dabigatran etexilate mesilate 150 mg b.i.d. (oral administration of one capsule twice daily)
|
|---|---|
|
Percentage of Participants With Stroke
Yes
|
0.30 percentage of participants
|
|
Percentage of Participants With Stroke
No
|
99.70 percentage of participants
|
SECONDARY outcome
Timeframe: up to 26 weeksPopulation: Effectiveness Analysis set
Systemic embolism was defined as an acute vascular occlusion of the extremities or any organ (kidneys, mesenteric arteries, spleen, retina or grafts) and was to be documented by angiography, surgery, scintigraphy or autopsy.
Outcome measures
| Measure |
Pradaxa Group
n=2311 Participants
Physician carefully reviewed the special precautions for use in patients with risk of bleeding before determining the dose of Pradaxa and patients were prescribed dabigatran dose for 24±2 weeks from the options described below:
* Dabigatran etexilate mesilate 110 mg b.i.d. (oral administration of one capsule twice daily )
* Dabigatran etexilate mesilate 150 mg b.i.d. (oral administration of one capsule twice daily)
|
|---|---|
|
Percentage of Participants With Systemic Embolism
No
|
100.0 percentage of participants
|
Adverse Events
Pradaxa Group
Serious events: 104 serious events
Other events: 0 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Pradaxa Group
n=3053 participants at risk
Physician carefully reviewed the special precautions for use in patients with risk of bleeding before determining the dose of Pradaxa and patients were prescribed dabigatran dose for 24±2 weeks from the options described below:
* Dabigatran etexilate mesilate 110 mg b.i.d. (oral administration of one capsule twice daily )
* Dabigatran etexilate mesilate 150 mg b.i.d. (oral administration of one capsule twice daily)
|
|---|---|
|
Gastrointestinal disorders
Dyspepsia
|
0.07%
2/3053 • All adverse events occurring from the start of Pradaxa treatment up to 7 days after last follow-up visit; up to 26 weeks
|
|
Gastrointestinal disorders
Gastritis
|
0.03%
1/3053 • All adverse events occurring from the start of Pradaxa treatment up to 7 days after last follow-up visit; up to 26 weeks
|
|
Gastrointestinal disorders
Haematochezia
|
0.10%
3/3053 • All adverse events occurring from the start of Pradaxa treatment up to 7 days after last follow-up visit; up to 26 weeks
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.03%
1/3053 • All adverse events occurring from the start of Pradaxa treatment up to 7 days after last follow-up visit; up to 26 weeks
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.03%
1/3053 • All adverse events occurring from the start of Pradaxa treatment up to 7 days after last follow-up visit; up to 26 weeks
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.03%
1/3053 • All adverse events occurring from the start of Pradaxa treatment up to 7 days after last follow-up visit; up to 26 weeks
|
|
Gastrointestinal disorders
Haematemesis
|
0.03%
1/3053 • All adverse events occurring from the start of Pradaxa treatment up to 7 days after last follow-up visit; up to 26 weeks
|
|
Gastrointestinal disorders
Ileus paralytic
|
0.03%
1/3053 • All adverse events occurring from the start of Pradaxa treatment up to 7 days after last follow-up visit; up to 26 weeks
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.03%
1/3053 • All adverse events occurring from the start of Pradaxa treatment up to 7 days after last follow-up visit; up to 26 weeks
|
|
Nervous system disorders
Dizziness
|
0.03%
1/3053 • All adverse events occurring from the start of Pradaxa treatment up to 7 days after last follow-up visit; up to 26 weeks
|
|
Nervous system disorders
Headache
|
0.03%
1/3053 • All adverse events occurring from the start of Pradaxa treatment up to 7 days after last follow-up visit; up to 26 weeks
|
|
Nervous system disorders
Cerebral infarction
|
0.36%
11/3053 • All adverse events occurring from the start of Pradaxa treatment up to 7 days after last follow-up visit; up to 26 weeks
|
|
Nervous system disorders
Transient ischaemic attack
|
0.23%
7/3053 • All adverse events occurring from the start of Pradaxa treatment up to 7 days after last follow-up visit; up to 26 weeks
|
|
Nervous system disorders
Cerebrovascular accident
|
0.13%
4/3053 • All adverse events occurring from the start of Pradaxa treatment up to 7 days after last follow-up visit; up to 26 weeks
|
|
Nervous system disorders
Dementia
|
0.03%
1/3053 • All adverse events occurring from the start of Pradaxa treatment up to 7 days after last follow-up visit; up to 26 weeks
|
|
Nervous system disorders
Dysarthria
|
0.07%
2/3053 • All adverse events occurring from the start of Pradaxa treatment up to 7 days after last follow-up visit; up to 26 weeks
|
|
Nervous system disorders
Tremor
|
0.03%
1/3053 • All adverse events occurring from the start of Pradaxa treatment up to 7 days after last follow-up visit; up to 26 weeks
|
|
Nervous system disorders
Dizziness postural
|
0.03%
1/3053 • All adverse events occurring from the start of Pradaxa treatment up to 7 days after last follow-up visit; up to 26 weeks
|
|
Nervous system disorders
Brain stem infarction
|
0.03%
1/3053 • All adverse events occurring from the start of Pradaxa treatment up to 7 days after last follow-up visit; up to 26 weeks
|
|
Nervous system disorders
Cerebellar infarction
|
0.03%
1/3053 • All adverse events occurring from the start of Pradaxa treatment up to 7 days after last follow-up visit; up to 26 weeks
|
|
Nervous system disorders
Epilepsy
|
0.03%
1/3053 • All adverse events occurring from the start of Pradaxa treatment up to 7 days after last follow-up visit; up to 26 weeks
|
|
Nervous system disorders
Seizure
|
0.03%
1/3053 • All adverse events occurring from the start of Pradaxa treatment up to 7 days after last follow-up visit; up to 26 weeks
|
|
Nervous system disorders
Status epilepticus
|
0.03%
1/3053 • All adverse events occurring from the start of Pradaxa treatment up to 7 days after last follow-up visit; up to 26 weeks
|
|
General disorders
Chest discomfort
|
0.03%
1/3053 • All adverse events occurring from the start of Pradaxa treatment up to 7 days after last follow-up visit; up to 26 weeks
|
|
General disorders
Asthenia
|
0.03%
1/3053 • All adverse events occurring from the start of Pradaxa treatment up to 7 days after last follow-up visit; up to 26 weeks
|
|
General disorders
Oedema
|
0.03%
1/3053 • All adverse events occurring from the start of Pradaxa treatment up to 7 days after last follow-up visit; up to 26 weeks
|
|
General disorders
Death
|
0.03%
1/3053 • All adverse events occurring from the start of Pradaxa treatment up to 7 days after last follow-up visit; up to 26 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.10%
3/3053 • All adverse events occurring from the start of Pradaxa treatment up to 7 days after last follow-up visit; up to 26 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.03%
1/3053 • All adverse events occurring from the start of Pradaxa treatment up to 7 days after last follow-up visit; up to 26 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.03%
1/3053 • All adverse events occurring from the start of Pradaxa treatment up to 7 days after last follow-up visit; up to 26 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.07%
2/3053 • All adverse events occurring from the start of Pradaxa treatment up to 7 days after last follow-up visit; up to 26 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.03%
1/3053 • All adverse events occurring from the start of Pradaxa treatment up to 7 days after last follow-up visit; up to 26 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.03%
1/3053 • All adverse events occurring from the start of Pradaxa treatment up to 7 days after last follow-up visit; up to 26 weeks
|
|
Cardiac disorders
Atrial fibrillation
|
0.20%
6/3053 • All adverse events occurring from the start of Pradaxa treatment up to 7 days after last follow-up visit; up to 26 weeks
|
|
Cardiac disorders
Atrial flutter
|
0.03%
1/3053 • All adverse events occurring from the start of Pradaxa treatment up to 7 days after last follow-up visit; up to 26 weeks
|
|
Cardiac disorders
Angina pectoris
|
0.03%
1/3053 • All adverse events occurring from the start of Pradaxa treatment up to 7 days after last follow-up visit; up to 26 weeks
|
|
Cardiac disorders
Acute myocardial infarction
|
0.07%
2/3053 • All adverse events occurring from the start of Pradaxa treatment up to 7 days after last follow-up visit; up to 26 weeks
|
|
Cardiac disorders
Cardiac failure congestive
|
0.03%
1/3053 • All adverse events occurring from the start of Pradaxa treatment up to 7 days after last follow-up visit; up to 26 weeks
|
|
Cardiac disorders
Coronary artery disease
|
0.03%
1/3053 • All adverse events occurring from the start of Pradaxa treatment up to 7 days after last follow-up visit; up to 26 weeks
|
|
Cardiac disorders
Pericardial effusion
|
0.03%
1/3053 • All adverse events occurring from the start of Pradaxa treatment up to 7 days after last follow-up visit; up to 26 weeks
|
|
Cardiac disorders
Sinus node dysfunction
|
0.03%
1/3053 • All adverse events occurring from the start of Pradaxa treatment up to 7 days after last follow-up visit; up to 26 weeks
|
|
Cardiac disorders
Angina unstable
|
0.03%
1/3053 • All adverse events occurring from the start of Pradaxa treatment up to 7 days after last follow-up visit; up to 26 weeks
|
|
Cardiac disorders
Cardiac arrest
|
0.03%
1/3053 • All adverse events occurring from the start of Pradaxa treatment up to 7 days after last follow-up visit; up to 26 weeks
|
|
Cardiac disorders
Cardiac failure acute
|
0.03%
1/3053 • All adverse events occurring from the start of Pradaxa treatment up to 7 days after last follow-up visit; up to 26 weeks
|
|
Cardiac disorders
Cardiac failure
|
0.03%
1/3053 • All adverse events occurring from the start of Pradaxa treatment up to 7 days after last follow-up visit; up to 26 weeks
|
|
Cardiac disorders
Mitral valve disease mixed
|
0.03%
1/3053 • All adverse events occurring from the start of Pradaxa treatment up to 7 days after last follow-up visit; up to 26 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.07%
2/3053 • All adverse events occurring from the start of Pradaxa treatment up to 7 days after last follow-up visit; up to 26 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.03%
1/3053 • All adverse events occurring from the start of Pradaxa treatment up to 7 days after last follow-up visit; up to 26 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.03%
1/3053 • All adverse events occurring from the start of Pradaxa treatment up to 7 days after last follow-up visit; up to 26 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.03%
1/3053 • All adverse events occurring from the start of Pradaxa treatment up to 7 days after last follow-up visit; up to 26 weeks
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.03%
1/3053 • All adverse events occurring from the start of Pradaxa treatment up to 7 days after last follow-up visit; up to 26 weeks
|
|
Musculoskeletal and connective tissue disorders
Soft tissue necrosis
|
0.03%
1/3053 • All adverse events occurring from the start of Pradaxa treatment up to 7 days after last follow-up visit; up to 26 weeks
|
|
Infections and infestations
Cellulitis
|
0.10%
3/3053 • All adverse events occurring from the start of Pradaxa treatment up to 7 days after last follow-up visit; up to 26 weeks
|
|
Infections and infestations
Pneumonia
|
0.03%
1/3053 • All adverse events occurring from the start of Pradaxa treatment up to 7 days after last follow-up visit; up to 26 weeks
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.03%
1/3053 • All adverse events occurring from the start of Pradaxa treatment up to 7 days after last follow-up visit; up to 26 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
0.03%
1/3053 • All adverse events occurring from the start of Pradaxa treatment up to 7 days after last follow-up visit; up to 26 weeks
|
|
Infections and infestations
Clonorchiasis
|
0.03%
1/3053 • All adverse events occurring from the start of Pradaxa treatment up to 7 days after last follow-up visit; up to 26 weeks
|
|
Infections and infestations
Encephalitis
|
0.03%
1/3053 • All adverse events occurring from the start of Pradaxa treatment up to 7 days after last follow-up visit; up to 26 weeks
|
|
Infections and infestations
Influenza
|
0.03%
1/3053 • All adverse events occurring from the start of Pradaxa treatment up to 7 days after last follow-up visit; up to 26 weeks
|
|
Infections and infestations
Sepsis
|
0.03%
1/3053 • All adverse events occurring from the start of Pradaxa treatment up to 7 days after last follow-up visit; up to 26 weeks
|
|
Infections and infestations
Tooth abscess
|
0.03%
1/3053 • All adverse events occurring from the start of Pradaxa treatment up to 7 days after last follow-up visit; up to 26 weeks
|
|
Renal and urinary disorders
Haematuria
|
0.10%
3/3053 • All adverse events occurring from the start of Pradaxa treatment up to 7 days after last follow-up visit; up to 26 weeks
|
|
Renal and urinary disorders
Acute kidney injury
|
0.07%
2/3053 • All adverse events occurring from the start of Pradaxa treatment up to 7 days after last follow-up visit; up to 26 weeks
|
|
Vascular disorders
Hypotension
|
0.03%
1/3053 • All adverse events occurring from the start of Pradaxa treatment up to 7 days after last follow-up visit; up to 26 weeks
|
|
Vascular disorders
Haemorrhage
|
0.07%
2/3053 • All adverse events occurring from the start of Pradaxa treatment up to 7 days after last follow-up visit; up to 26 weeks
|
|
Vascular disorders
Aortic aneurysm
|
0.03%
1/3053 • All adverse events occurring from the start of Pradaxa treatment up to 7 days after last follow-up visit; up to 26 weeks
|
|
Vascular disorders
Arterial rupture
|
0.03%
1/3053 • All adverse events occurring from the start of Pradaxa treatment up to 7 days after last follow-up visit; up to 26 weeks
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.03%
1/3053 • All adverse events occurring from the start of Pradaxa treatment up to 7 days after last follow-up visit; up to 26 weeks
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.03%
1/3053 • All adverse events occurring from the start of Pradaxa treatment up to 7 days after last follow-up visit; up to 26 weeks
|
|
Injury, poisoning and procedural complications
Fracture
|
0.03%
1/3053 • All adverse events occurring from the start of Pradaxa treatment up to 7 days after last follow-up visit; up to 26 weeks
|
|
Injury, poisoning and procedural complications
Radiation proctitis
|
0.03%
1/3053 • All adverse events occurring from the start of Pradaxa treatment up to 7 days after last follow-up visit; up to 26 weeks
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.03%
1/3053 • All adverse events occurring from the start of Pradaxa treatment up to 7 days after last follow-up visit; up to 26 weeks
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.03%
1/3053 • All adverse events occurring from the start of Pradaxa treatment up to 7 days after last follow-up visit; up to 26 weeks
|
|
Injury, poisoning and procedural complications
Subarachnoid hemorrhage
|
0.03%
1/3053 • All adverse events occurring from the start of Pradaxa treatment up to 7 days after last follow-up visit; up to 26 weeks
|
|
Eye disorders
Cataract
|
0.03%
1/3053 • All adverse events occurring from the start of Pradaxa treatment up to 7 days after last follow-up visit; up to 26 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.07%
2/3053 • All adverse events occurring from the start of Pradaxa treatment up to 7 days after last follow-up visit; up to 26 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.07%
2/3053 • All adverse events occurring from the start of Pradaxa treatment up to 7 days after last follow-up visit; up to 26 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.07%
2/3053 • All adverse events occurring from the start of Pradaxa treatment up to 7 days after last follow-up visit; up to 26 weeks
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.03%
1/3053 • All adverse events occurring from the start of Pradaxa treatment up to 7 days after last follow-up visit; up to 26 weeks
|
|
Hepatobiliary disorders
Alcoholic liver disease
|
0.03%
1/3053 • All adverse events occurring from the start of Pradaxa treatment up to 7 days after last follow-up visit; up to 26 weeks
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.03%
1/3053 • All adverse events occurring from the start of Pradaxa treatment up to 7 days after last follow-up visit; up to 26 weeks
|
Other adverse events
Adverse event data not reported
Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER